[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Notices]
[Pages 38071-38083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0161]
Medical Devices; Reprocessed Single-Use Devices; Termination of
Exemptions From Premarket Notification; Requirement for Submission of
Validation Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is adding nonelectric
biopsy forceps (classified in 21 CFR 876.1075, Gastroenterology-urology
biopsy instrument) to the list of critical reprocessed single-use
devices (SUDs) whose exemption from premarket notification requirements
is being terminated and for which validation data, as specified under
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is
necessary in a premarket notification (510(k)). FDA is requiring
submission of these data to ensure that reprocessed single-use
nonelectric biopsy forceps are substantially equivalent to predicate
devices, in accordance with MDUFMA.
DATES: These actions are effective June 26, 2003. Manufacturers of
reprocessed
[[Page 38072]]
single-use biopsy forceps must submit 510(k)s for these devices by
September 27, 2004, or their devices may no longer be marketed.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments should be identified with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Barbara A. Zimmerman, Center for
Devices and Radiological Health (HFZ-410), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250) amended the
Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o)
(21 U.S.C. 360(o)), which provided new regulatory requirements for
reprocessed SUDs. According to this new provision, in order to ensure
that reprocessed SUDs are substantially equivalent to predicate
devices, 510(k)s for certain reprocessed SUDs identified by FDA must
include validation data. These required validation data include
cleaning and sterilization data, and functional performance data
demonstrating that each SUD will remain substantially equivalent to its
predicate device after the maximum number of times the device is
reprocessed as intended by the person submitting the premarket
notification.
Before enactment of the new law, a manufacturer of a reprocessed
SUD was required to obtain premarket approval or premarket clearance
for the device, unless the device was exempt from premarket submission
requirements. Under MDUFMA, some previously exempt reprocessed SUDs
will no longer be exempt from premarket notification requirements.
Manufacturers of these identified devices will need to submit 510(k)s
that include validation data to be specified by FDA. Reprocessors of
certain SUDs that currently have cleared 510(k)s also will need to
submit the validation data specified by the agency.
A. Definitions
Under section 302(d) of MDUFMA, a reprocessed SUD is defined as an
``* * * original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a
patient. The subsequent processing and manufacture of a reprocessed
single-use device shall result in a device that is reprocessed
within the meaning of this definition.''
B. Reprocessed SUDs Exempt From Premarket Notification
Reprocessed SUDs are divided into three groups: (1) Critical, (2)
semicritical, and (3) noncritical. The first two categories reflect
definitions set forth in MDUFMA, and all three reflect a classification
scheme recognized by the industry.\1\ These categories of devices are
defined as follows:
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\1\ These are known in the industry as the Spaulding
definitions, and are described in Spaulding, E. H., ``The Role of
Chemical Disinfection in the Prevention of Nonsocomial Infections,''
P. S. Brachman and T. C. Eickof (ed), Proceedings of International
Conference on Nonsocomial Infections, 1970, American Hospital
Association, Chicago, IL 1971:254-274.
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1. A critical reprocessed SUD is intended to contact normally
sterile tissue or body spaces during use.
2. A semicritical reprocessed SUD is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the body.
3. A noncritical reprocessed SUD is intended to make topical
contact and not penetrate intact skin.
C. Requirements for Critical Reprocessed SUDs
MDUFMA requires FDA to review the critical reprocessed SUDs that
are currently exempt from premarket notification requirements and
determine which of these devices require premarket notification to
ensure their substantial equivalence to predicate devices. By April 26,
2003, FDA was required to identify in a Federal Register notice those
critical reprocessed SUDs whose exemption from premarket notification
requirements will be terminated and for which FDA has determined that
validation data, as specified under MDUFMA, is necessary in a 510(k).
According to the new law, manufacturers of the devices whose exemption
from premarket notification requirements is terminated must submit
510(k)s that include validation data regarding cleaning, sterilization,
and functional performance, in addition to all the other required
elements of a 510(k) identified in 21 CFR 807.87, within 15 months of
publication of the list or no longer market their devices.
II. FDA's Implementation of New Section 510(o) of the Act
In the Federal Register of April 30, 2003 (68 FR 23139), FDA
described the methodology and criteria it used to determine which
previously exempt critical reprocessed SUDs are now subject to 510(k)
submission requirements, including the submission of validation data.
First, FDA described how it identified the types of SUDs being
reprocessed and how the Spaulding definitions (see footnote 1) were
used to categorize these devices as critical, semicritical, or
noncritical. (This list, which was Attachment 1 to that Federal
Register notice, is being reprinted as Attachment 1 to this notice.)
Next, the agency described its use of the Risk Prioritization Scheme
(RPS)\2\ that it used to evaluate the risk (high, moderate, or low)
associated with an SUD based on: (1) Risk of infection and (2) risk of
inadequate performance following reprocessing. FDA identified its final
risk criterion as those reprocessed SUDs intended to come in contact
with tissue at high risk of being infected with the causative agents of
Creutzfeldt-Jakob Disease (CJD). (These are generally devices intended
for use in neurosurgery and ophthalmology.)
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\2\ This scheme is described in the agency's February 2000 draft
guidance document entitled ``Reprocessing and Reuse of Single-Use
Devices: Review Prioritization Scheme.'' The document is available
on the Internet at http://www.fda.gov/cdrh/reuse/1156.pdf.
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Using this methodology and criteria, the devices included in List I
(``Critical Reprocessed Single-Use Devices Previously Exempt From
Premarket Notification Requirements That Will Now Require 510(k)s With
Validation Data'') of the April 30, 2003, Federal Register notice are
those critical reprocessed SUDs that were either high risk according to
the RPS or intended to come in contact with tissue at high risk of
being infected with the causative agents of CJD.
III. Revisions to Attachment I, List I, and List II
A. Revisions to Attachment I (List of SUDs Known To Be Reprocessed or
Considered for Reprocessing)
FDA has re-evaluated the list of reprocessed SUDs with regard to
the critical and semicritical device designations. In doing so, the
agency has determined that all gastroenterology-urology biopsy
instruments should be considered critical devices rather than
semicritical devices because these devices are intended to break the
mucous membrane and come in contact with sterile tissue when taking a
biopsy. This includes biopsy forceps covers, biopsy instruments, biopsy
needle sets, biopsy punches, mechanical biopsy instruments, and
nonelectric biopsy
[[Page 38073]]
forceps (devices 42-47 in Attachment I). In addition, it was determined
that rigid and nonrigid bronchoscope biopsy forceps and biliary
sphincterotomes (devices 40, 41, and 55 in Attachment I) should also be
considered critical devices rather than semicritical devices for the
same reason as stated previously. These changes are reflected in a
revised version of Attachment I included in this Federal Register
notice.
B. Revisions to List I (Critical Reprocessed Single-Use Devices
Previously Exempt From Premarket Notification Requirements That Will
Now Require 510(k)s With Validation Data)
FDA recategorized nine device types from semicritical to critical.
One of these nine device types, nonelectric gastroenterology-urology
biopsy forceps, was also considered high risk under the RPS. Therefore,
nonelectric gastroenterology-urology biopsy forceps have been added to
List I. Under MDUFMA, manufacturers of these biopsy forceps will be
required to submit 510(k)s with validation data by (see DATES), which
is 15 months following the publication of this revised list.
In addition, FDA is taking this opportunity to clarify the date by
which manufacturers of the other devices in List I are required to
submit 510(k)s with validation data. The correct date is July 30, 2004,
which is 15 months following the initial publication of the list (the
April 30, 2003, Federal Register notice inadvertently identified two
dates).
C. Revisions to List II (Reprocessed Single-Use Devices Subject to
Premarket Notification Requirements That Will Now Require the
Submission of Validation Data)
The only change to List II is to clarify the date by which 510(k)
submissions are required by MDUFMA to be supplemented with validation
data. The correct date is January 30, 2004, which is 9 months following
the initial publication of the list (as noted previously, the April 30,
2003, Federal Register notice inadvertently identified two dates).
List I.--Critical Reprocessed Single-Use Devices Previously Exempt From
Premarket Notification Requirements That Will Now Require 510(k)s With
Validation Data (to be submitted by July 30, 2004, unless otherwise
noted).
------------------------------------------------------------------------
Product code Product code Product code
21 CFR Classification for non- for name for
section name reprocessed reprocessed reprocessed
device device device
------------------------------------------------------------------------
872.3240 Dental bur Diamond NME Dental diamond
coated coated bur
------------------------------------------------------------------------
872.4535 Dental diamond DZP NLD Dental diamond
instrument instrument
------------------------------------------------------------------------
872.4730 Dental injection DZM NMW Dental needle
needle
------------------------------------------------------------------------
874.4140 Ear, nose, and Microdebrider NLY ENT high speed
throat (ENT) microdebrider
bur
------------------------------------------------------------------------
874.4140 Ear, nose, and Diamond NLZ ENT diamond
throat bur coated coated bur
------------------------------------------------------------------------
874.4420 Ear, nose, KAB, KBG, KCI NLB Laryngeal,
throat manual sinus,
surgical tracheal
instrument trocar
------------------------------------------------------------------------
876.1075\ Gastroenterology- FCL NON Nonelectric
1\ urology biopsy biopsy
instrument forceps
------------------------------------------------------------------------
878.4200 Introduction/ GCB NMT Catheter
drainage needle
catheter and
accessories
------------------------------------------------------------------------
878.4800 Manual surgical MJG NNA Percutaneous
instrument biopsy device
------------------------------------------------------------------------
878.4800 Manual surgical FHR NMU Gastro-urology
instrument needle
------------------------------------------------------------------------
878.4800 Manual surgical DWO NLK Cardiovascular
instrument for biopsy needle
general use
------------------------------------------------------------------------
878.4800 Manual surgical GAA NNC Aspiration and
instrument for injection
general use needle
------------------------------------------------------------------------
882.4190 Forming/cutting HBS NMN Forming/
clip instrument cutting clip
instrument
------------------------------------------------------------------------
884.1730 Laparoscopic HIF NMI Laparoscopic
insufflator insufflator
and
accessories
------------------------------------------------------------------------
884.4530 OB/GYN HFB NMG Gynecological
specialized biopsy
manual forceps
instrument
------------------------------------------------------------------------
886.4350 Manual HNN NLA Ophthalmic
ophthalmic knife
surgical
instrument
------------------------------------------------------------------------
\1\ 510(k)s with validation data to be submitted by September 27, 2004.
[[Page 38074]]
List II.--Reprocessed Single-Use Devices Subject to Premarket
Notification Requirements That Will Now Require the Submission of
Validation Data\1\ (Manufacturers who already have 510(k) clearance for
these devices must submit validation data by January 30, 2004. Any new
510(k) submitted after publication of the April 30 list will require
validation data.)
------------------------------------------------------------------------
Product code Product code Product code
21 CFR Classification for non- for name for
section name reprocessed reprocessed reprocessed
device device device
------------------------------------------------------------------------
Unclassif Oocyte MHK NMO Oocyte
ied aspiration aspiration
needles needles
------------------------------------------------------------------------
Unclassif Percutaneous LIT NMM Transluminal
ied transluminal peripheral
angioplasty angioplasty
catheter catheter
------------------------------------------------------------------------
Unclassif Ultrasonic LFL NLQ Ultrasonic
ied surgical scalpel
instrument
------------------------------------------------------------------------
868.5150 Anesthesia BSP NNH Anesthetic
conduction conduction
needle needle (with
or without
introducer)
------------------------------------------------------------------------
868.5150 Anesthesia MIA NMR Short term
conduction spinal needle
needle
------------------------------------------------------------------------
868.5730 Tracheal tube BTR NMA Tracheal tube
(with or
without
connector)
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868.5905 Noncontinuous BZD NMC Noncontinuous
ventilator ventilator
(IPPB) (respirator)
mask
------------------------------------------------------------------------
870.1200 Diagnostic DQO NLI Angiography
intravascular catheter
catheter
------------------------------------------------------------------------
870.1220 Electrode DRF NLH Electrode
recording recording
catheter catheter
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870.1220 Electrode MTD NLG Intracardiac
recording mapping
catheter catheter
------------------------------------------------------------------------
870.1230 Fiberoptic DQE NMB Fiberoptic
oximeter oximeter
catheter catheter
------------------------------------------------------------------------
870.1280 Steerable DRA NKS Steerable
catheter catheter
------------------------------------------------------------------------
870.1290 Steerable DXX NKR Steerable
catheter catheter
control system control
system
------------------------------------------------------------------------
870.1330 Catheter guide DQX NKQ Catheter guide
wire wire
------------------------------------------------------------------------
870.1390 Trocar DRC NMK Cardiovascular
trocar
------------------------------------------------------------------------
870.1650 Angiographic DXT NKT Angiographic
injector and injector and
syringe syringe
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870.1670 Syringe actuator DQF NKW Injector for
for injector actuator
syringe
------------------------------------------------------------------------
870.2700 Oximeter MUD NMD Tissue
saturation
oximeter
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870.2700 Oximeter DQA NLF Oximeter
------------------------------------------------------------------------
870.3535 Intra-aortic DSP NKO Intra-aortic
balloon and balloon and
control system control
system
------------------------------------------------------------------------
870.4450 Vascular clamp DXC NMF Vascular clamp
------------------------------------------------------------------------
870.4885 External vein DWQ NLJ External vein
stripper stripper
------------------------------------------------------------------------
872.5470 Orthodontic DYW NLC Orthodontic
plastic bracket plastic
bracket
------------------------------------------------------------------------
874.4680 Bronchoscope BWH NLE Bronchoscope
(flexible or (nonrigid)
rigid) and biopsy
accessories forceps
------------------------------------------------------------------------
876.1075 Gastro-urology FCG NMX G-U biopsy
biopsy needle and
instrument needle set
------------------------------------------------------------------------
876.1075 Gastroenterology- KNW NLS Biopsy
urology biopsy instrument
instrument
------------------------------------------------------------------------
876.1500 Endoscope and FBK, FHP NMY Endoscopic
accessories needle
------------------------------------------------------------------------
876.1500 Endoscope and MPA NKZ Endoilluminato
accessories r
------------------------------------------------------------------------
876.1500 Endoscope and GCJ NLM General and
accessories plastic
surgery
laparoscope
------------------------------------------------------------------------
876.1500 Endoscope and FHO NLX Spring-loaded
accessories Pneumoperiton
eum Needle
------------------------------------------------------------------------
[[Page 38075]]
876.4300 Endoscopic FAS NLW Active
electrosurgical urological
unit and electrosurgic
accessories al electrode
------------------------------------------------------------------------
876.4300 Endoscopic FEH NLV Flexible
electrosurgical suction
unit and coagulator
accessories electrode
------------------------------------------------------------------------
876.4300 Endoscopic KGE NLU Electric
electrosurgical biopsy
unit and forceps
accessories
------------------------------------------------------------------------
876.4300 Endoscopic FDI NLT Flexible snare
electrosurgical
unit and
accessories
------------------------------------------------------------------------
876.4300 Endoscopic KNS NLR Endoscopic
electrosurgical (with or
unit and without
accessories accessories)
Electrosurgic
al unit
------------------------------------------------------------------------
876.5010 Biliary catheter FGE NML Biliary
and accessories catheter
------------------------------------------------------------------------
876.5540 Blood access LBW NNF Single needle
device and dialysis set
accessories (co-axial
flow)
------------------------------------------------------------------------
876.5540 Blood access FIE NNE Fistula needle
device and
accessories
------------------------------------------------------------------------
876.5820 Hemodialysis FIF NNG Single needle
systems and dialysis set
accessories with uni-
directional
pump
------------------------------------------------------------------------
878.4300 Implantable clip FZP NMJ Implantable
clip
------------------------------------------------------------------------
878.4750 Implantable GDW NLL Implantable
staple staple
------------------------------------------------------------------------
880.5570 Hypodermic FMI NKK Hypodermic
single lumen single lumen
needle needle
------------------------------------------------------------------------
880.5860 Piston syringe FMF NKN Piston syringe
------------------------------------------------------------------------
882.4300 Manual cranial HBG NLO (Manual)
drills, burrs, drills,
trephines, and burrs,
accessories trephines,
and
accessories
------------------------------------------------------------------------
882.4305 Powered compound HBF NLP (Powered,
cranial drills, compound)
burrs, drills,
trephines, and burrs,
accessories trephines,
and
accessories
------------------------------------------------------------------------
882.4310 Powered simple HBE NLN (Simple,
cranial drills, powered)
burrs, drills,
trephines, and burrs,
accessories trephines,
and
accessories
------------------------------------------------------------------------
884.1720 Gynecologic HET NMH Gynecologic
laparoscope and laparoscope
accessories (and
accessories)
------------------------------------------------------------------------
884.6100 Assisted MQE NNB Assisted
reproduction reproduction
needles needles
------------------------------------------------------------------------
886.4370 Keratome HMY, HNO NKY Keratome blade
------------------------------------------------------------------------
886.4670 Phacofragmentati HQC NKX Phacoemulsific
on system ation needle
------------------------------------------------------------------------
892.5730 Radionuclide IWF NMP Isotope needle
brachytherapy
source
------------------------------------------------------------------------
\1\ Hemodialyzers have been excluded from this list because the reuse of
hemodialyzers is addressed in FDA's ``Guidance for Hemodialyzer Reuse
Labeling'' (final draft issued on October 6, 1995).
IV. Comments
You may submit written or electronic comments on this notice to the
Division of Dockets Management (see ADDRESSES). You may submit a single
copy of an electronic comment to http://www.fda.gov/dockets/ecomments.
You should submit two paper copies of any mailed comments but
individuals may submit one paper copy. You should identify your comment
with the docket number found in brackets in the heading of this
document. You may see any comments FDA receives in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 38076]]
Attachment 1--List of SUDs Known To Be Reprocessed or Considered for Reprocessing June 26, 2003
----------------------------------------------------------------------------------------------------------------
Critical/semi-
Medical Device type 21 CFR Class Product Risk* critical/ Premarket
specialty section code noncritical exempt
----------------------------------------------------------------------------------------------------------------
1 Cardio Cardiopulmonary unclassifi ........ MAB 1 C N\1\
Bypass Marker ed
----------------------------------------------------------------------------------------------------------------
2 Cardio Percutaneous & post- III LOX 3 C N
Operative amendment
Transluminal
Coronary
Angioplasty
Catheter (PTCA)
----------------------------------------------------------------------------------------------------------------
3 Cardio Percutaneous post- III LPB 3 C N
Ablation amendment
Electrode
----------------------------------------------------------------------------------------------------------------
4 Cardio Peripheral unclassifi ........ LIT 3 C N
Transluminal ed
Angioplasty
(PTA) Catheter
----------------------------------------------------------------------------------------------------------------
5 Cardio Blood-Pressure 870.1120 II DXQ 1 N N
Cuff
----------------------------------------------------------------------------------------------------------------
6 Cardio Angiography 870.1200 II DQO 3 C N
Catheter
----------------------------------------------------------------------------------------------------------------
7 Cardio Electrode 870.1220 II DRF 3 C N
Recording
Catheter
----------------------------------------------------------------------------------------------------------------
8 Cardio High-Density 870.1220 II MTD 3 C N
Array Catheter
----------------------------------------------------------------------------------------------------------------
9 Cardio Fiberoptic 870.1230 II DQE 3 C N
Oximeter
Catheter
----------------------------------------------------------------------------------------------------------------
10 Cardio Steerable 870.1280 II DRA 3 C N
Catheter
----------------------------------------------------------------------------------------------------------------
11 Cardio Steerable 870.1290 II DXX 3 C N
Catheter
Control System
----------------------------------------------------------------------------------------------------------------
12 Cardio Guide Wire 870.1330 II DQX 3 C N
----------------------------------------------------------------------------------------------------------------
13 Cardio Angiographic 870.1390 II DRC 3 C N
Needle
----------------------------------------------------------------------------------------------------------------
14 Cardio Trocar 870.1390 II DRC 3 C N
----------------------------------------------------------------------------------------------------------------
15 Cardio Syringes 870.1650 II DXT 3 C N
----------------------------------------------------------------------------------------------------------------
16 Cardio Injector Type 870.1670 II DQF 3 C N
Syringe
Actuator
----------------------------------------------------------------------------------------------------------------
17 Cardio Oximeter 870.2700 II DQA 3 N N
----------------------------------------------------------------------------------------------------------------
18 Cardio Tissue 870.2700 II MUD 3 C N
Saturation
Oximeter
----------------------------------------------------------------------------------------------------------------
19 Cardio Intra-Aortic 870.3535 III DSP 3 C N
Balloon System
----------------------------------------------------------------------------------------------------------------
20 Cardio Vascular Clamp 870.4450 II DXC 3 C N
----------------------------------------------------------------------------------------------------------------
21 Cardio Device, 870.4500 I MWS 2 C Y\2\
Stabilizer,
Heart
----------------------------------------------------------------------------------------------------------------
22 Cardio External Vein 870.4885 II DWQ 3 C N
Stripper
----------------------------------------------------------------------------------------------------------------
23 Cardio Compressible 870.5800 II JOW 1 N N
Limb Sleeve
----------------------------------------------------------------------------------------------------------------
24 Dental Bur 872.3240 I EJL 1 C Y
----------------------------------------------------------------------------------------------------------------
25 Dental Diamond Coated 872.3240 I EJL 3 C Y
Bur
----------------------------------------------------------------------------------------------------------------
26 Dental Diamond 872.4535 I DZP 3 C Y
Instrument
----------------------------------------------------------------------------------------------------------------
27 Dental AC-Powered Bone 872.4120 II DZH 2 C N
Saw
----------------------------------------------------------------------------------------------------------------
28 Dental Manual Bone 872.4120 II DZJ 2 C N
Drill and Wire
Driver
----------------------------------------------------------------------------------------------------------------
29 Dental Powered Bone 872.4120 II DZI 2 C N
Drill
----------------------------------------------------------------------------------------------------------------
30 Dental Intraoral Drill 872.4130 I DZA 1 C Y
----------------------------------------------------------------------------------------------------------------
31 Dental Injection needle 872.4730 I DZM 3 C Y
----------------------------------------------------------------------------------------------------------------
32 Dental Metal 872.5410 I EJF 3 S Y
Orthodontic
Bracket
----------------------------------------------------------------------------------------------------------------
[[Page 38077]]
33 Dental Plastic 872.5470 II DYW 3 S N
Orthodontic
Bracket
----------------------------------------------------------------------------------------------------------------
34 ENT Bur 874.4140 I EQJ 1 C Y
----------------------------------------------------------------------------------------------------------------
35 ENT Diamond Coated 874.4140 I EQJ 3 C Y
Bur
----------------------------------------------------------------------------------------------------------------
36 ENT Microdebrider 874.4140 I EQJ 3 C Y
----------------------------------------------------------------------------------------------------------------
37 ENT Microsurgical 874.4490 II LMS 1 S N
Argon Fiber
Optic Laser
Cable, for Uses
Other Than
Otology,
Including
Laryngology and
General Use in
Otolaryngology
----------------------------------------------------------------------------------------------------------------
38 ENT Microsurgical 874.4490 II LXR 1 S N
Argon Fiber
Optic Laser
Cable for Use
in Otology
----------------------------------------------------------------------------------------------------------------
39 ENT Microsurgical 874.4500 II EWG 1 S N
Carbon-Dioxide
Fiber Optic
Laser Cable
----------------------------------------------------------------------------------------------------------------
40 ENT Bronchoscope 874.4680 II BWH 3 C N
[dagg Biopsy Forceps
er] (Nonrigid)
----------------------------------------------------------------------------------------------------------------
41 ENT Bronchoscope 874.4680 II JEK 1 C N
[dagg Biopsy Forceps
er] (Rigid)
----------------------------------------------------------------------------------------------------------------
42 Gastro/ Biopsy Forceps 876.1075 I FFF 1 C Y
[dagg Urology Cover
er]
----------------------------------------------------------------------------------------------------------------
43 Gastro/ Biopsy 876.1075 II KNW 3 C N
[dagg Urology Instrument
er]
----------------------------------------------------------------------------------------------------------------
44 Gastro/ Biopsy Needle 876.1075 II FCG 3 C N
[dagg Urology Set
er]
----------------------------------------------------------------------------------------------------------------
45 Gastro/ Biopsy Punch 876.1075 II FCI 2 C N
[dagg Urology
er]
----------------------------------------------------------------------------------------------------------------
46 Gastro/ Mechanical 876.1075 II FCF 2 C N
[dagg Urology Biopsy
er] Instrument
----------------------------------------------------------------------------------------------------------------
47 Gastro/ Nonelectric 876.1075 I FCL 3 C Y
[dagg Urology Biopsy Forceps
er]
----------------------------------------------------------------------------------------------------------------
48 Gastro/ Cytology Brush 876.1500 II FDX 2 S N
Urology for Endoscope
----------------------------------------------------------------------------------------------------------------
49 Gastro/ Endoscope 876.1500 II KOG 2 S N
Urology accessories
----------------------------------------------------------------------------------------------------------------
50 Gastro/ Extraction 876.1500 II KOG 2 S N
Urology Balloons/
Baskets
----------------------------------------------------------------------------------------------------------------
51 Gastro/ Endoscopic 876.1500 II FBK 3 C N
Urology needle
----------------------------------------------------------------------------------------------------------------
52 Gastro/ Simple 876.1500 II FHP 3 C N
Urology Pneumoperitoneu
m Needle
----------------------------------------------------------------------------------------------------------------
53 Gastro/ Spring Loaded 876.1500 II FHO 3 C N
Urology Pneumoperitoneu
m Needle
----------------------------------------------------------------------------------------------------------------
54 Gastro/ Active 876.4300 II FAS 3 S N
Urology Electrosurgical
Electrode
----------------------------------------------------------------------------------------------------------------
55 Gastro/ Biliary 876.5010, II FGE 3 C N
[dagg Urology Sphincterotomes 876.1500
er]
----------------------------------------------------------------------------------------------------------------
56 Gastro/ Electric Biopsy 876.4300 II KGE 3 C N
Urology Forceps
----------------------------------------------------------------------------------------------------------------
57 Gastro/ Electrosurgical 876.4300 II KNS 3 S N
Urology Endoscopic Unit
(With or
Without
Accessories)
----------------------------------------------------------------------------------------------------------------
58 Gastro/ Flexible Snare 876.4300 II FDI 3 S N
Urology
----------------------------------------------------------------------------------------------------------------
59 Gastro/ Flexible Suction 876.4300 II FEH 3 S N
Urology Coagulator
Electrode
----------------------------------------------------------------------------------------------------------------
[[Page 38078]]
60 Gastro/ Flexible Stone 876.4680 II FGO 3 S Y
Urology Dislodger
----------------------------------------------------------------------------------------------------------------
61 Gastro/ Metal Stone 876.4680 II FFL 3 S Y
Urology Dislodger
----------------------------------------------------------------------------------------------------------------
62 Gastro/ Needle Holder 876.4730 I FHQ 1 C Y
Urology
----------------------------------------------------------------------------------------------------------------
63 Gastro/ Nonelectrical 876.4730 I FGX 1 S Y
Urology Snare
----------------------------------------------------------------------------------------------------------------
64 Gastro/ Urological 876.5130 II KOD 2 S N
Urology Catheter
----------------------------------------------------------------------------------------------------------------
65 Gastro/ Single Needle 876.5540 II LBW, FIE 3 C N
Urology Dialysis Set
----------------------------------------------------------------------------------------------------------------
66 Gastro/ Hemodialysis 876.5820 II KOC 2 S N
Urology Blood Circuit
Accessories
----------------------------------------------------------------------------------------------------------------
67 Gastro/ Single Needle 876.5820 II FIF 3 C N
Urology Dialysis Set
----------------------------------------------------------------------------------------------------------------
68 GE/U Hemorrhoidal 876.4400 II FHN 2 C N
Ligator
----------------------------------------------------------------------------------------------------------------
69 General Implanted, post- III LKK 3 C N
Hospital Programmable amendment
Infusion Pump
----------------------------------------------------------------------------------------------------------------
70 General Needle post- III MTV 1 N N
Hospital Destruction amendment
Device
----------------------------------------------------------------------------------------------------------------
71 General Nonpowered 880.5150 I IKY 2 N Y
Hospital Flotation
Therapy
Mattress
----------------------------------------------------------------------------------------------------------------
72 General Non-AC-Powered 880.5510 I FSA 2 N Y
Hospital Patient Lift
----------------------------------------------------------------------------------------------------------------
73 General Alternating 880.5550 II FNM 1 N Y
Hospital Pressure Air
Flotation
Mattress
----------------------------------------------------------------------------------------------------------------
74 General Temperature 880.5560 I FOH 2 N Y
Hospital Regulated Water
Mattress
----------------------------------------------------------------------------------------------------------------
75 General Hypodermic 880.5570 II FMI 3 C N
Hospital Single Lumen
Needle
----------------------------------------------------------------------------------------------------------------
76 General Piston Syringe 880.5860 II FMF 3 C N
Hospital
----------------------------------------------------------------------------------------------------------------
77 General Mattress Cover 880.6190 I FMW 2 N Y
Hospital (Medical
Purposes)
----------------------------------------------------------------------------------------------------------------
78 General Disposable 880.6820 I JOK 1 N Y
Hospital Medical
Scissors
----------------------------------------------------------------------------------------------------------------
79 General Irrigating 880.6960 I KYZ, KYY 1 C Y
Hospital Syringe
----------------------------------------------------------------------------------------------------------------
80 Infection Surgical Gowns 878.4040 II FYA 1 C N
Control
----------------------------------------------------------------------------------------------------------------
81 Lab Blood Lancet 878.4800 I FMK 1 C Y
----------------------------------------------------------------------------------------------------------------
82 Neuro Clip Forming/ 882.4190 I HBS 3* C Y
Cutting
Instrument,
----------------------------------------------------------------------------------------------------------------
83 Neuro Drills, Burrs, 882.4300 II HBG 3* C N
Trephines, and
Accessories
(Manual)
----------------------------------------------------------------------------------------------------------------
84 Neuro Drills, Burrs, 882.4305 II HBF 3* C N
Trephines, and
Accessories
(Compound,
Powered)
----------------------------------------------------------------------------------------------------------------
85 Neuro Drills, Burrs, 882.4310 II HBE 3* C N
Trephines, and
Accessories
(Simple,
Powered)
----------------------------------------------------------------------------------------------------------------
86 OB/GYN Oocyte Unclassifi II MHK 3 C N
Aspiration ed
Needle
----------------------------------------------------------------------------------------------------------------
87 OB/GYN Laparoscope 884.1720 I HET 2 C Y
Accessories
----------------------------------------------------------------------------------------------------------------
[[Page 38079]]
88 OB/GYN Laparoscope 884.1720 II HET 3 C N
Accessories
----------------------------------------------------------------------------------------------------------------
89 OB/GYN Laparoscopic 884.1720 I HET 2 C Y
Dissectors
----------------------------------------------------------------------------------------------------------------
90 OB/GYN Laparoscopic 884.1720 I HET 2 C Y
Graspers
----------------------------------------------------------------------------------------------------------------
91 OB/GYN Laparoscopic 884.1720 I HET 2 C Y
Scissors
----------------------------------------------------------------------------------------------------------------
92 OB/GYN Insufflator 884.1730 II HIF 3 C Y
Accessories
(Tubing, Verres
Needle, Kits)
----------------------------------------------------------------------------------------------------------------
93 OB/GYN Laparoscopic 884.1730 II HIF 2 N N
Insufflator
----------------------------------------------------------------------------------------------------------------
94 OB/GYN Endoscopic 884.4100 II HIM 2 N N
Electrocautery
and Accessories
----------------------------------------------------------------------------------------------------------------
95 OB/GYN Gynecologic 884.4120 II HGI 2 N N
Electrocautery
(and
Accessories)
----------------------------------------------------------------------------------------------------------------
96 OB/GYN Endoscopic 884.4150 II HIN 2 N N
Bipolar
Coagulator-
Cutter (and
Accessories)
----------------------------------------------------------------------------------------------------------------
97 OB/GYN Culdoscopic 884.4160 II HFI 2 N N
Coagulator (and
Accessories)
----------------------------------------------------------------------------------------------------------------
98 OB/GYN Endoscopic 884.4160 II KNF 2 N N
Unipolar
Coagulator-
Cutter (and
Accessories)
----------------------------------------------------------------------------------------------------------------
99 OB/GYN Hysteroscopic 884.4160 II HFH 2 N N
Coagulator (and
Accessories)
----------------------------------------------------------------------------------------------------------------
100 OB/GYN Unipolar 884.4160 II HFG 2 N N
Laparoscopic
Coagulator (and
Accessories)
----------------------------------------------------------------------------------------------------------------
101 OB/GYN Episiotomy 884.4520 I HDK 1 C Y
Scissors
----------------------------------------------------------------------------------------------------------------
102 OB/GYN Umbilical 884.4520 I HDJ 1 C Y
Scissors
----------------------------------------------------------------------------------------------------------------
103 OB/GYN Biopsy Forceps 884.4530 I HFB 3 C Y
----------------------------------------------------------------------------------------------------------------
104 OB/GYN Assisted 884.6100 II MQE 3 C N
Reproduction
Needles
----------------------------------------------------------------------------------------------------------------
105 Ophthalmic Endoilluminator 876.1500 II MPA 3* C N
----------------------------------------------------------------------------------------------------------------
106 Ophthalmic Surgical Drapes 878.4370 II KKX 2 C N
----------------------------------------------------------------------------------------------------------------
107 Ophthalmic Ophthalmic Knife 886.4350 I HNN 3 C Y
----------------------------------------------------------------------------------------------------------------
108 Ophthalmic Keratome Blade 886.4370 I not HMY, HNO 3 C N
exempt
----------------------------------------------------------------------------------------------------------------
109 Ophthalmic Phacoemulsificat 886.4670 II HQC 3 C N
ion Needle
----------------------------------------------------------------------------------------------------------------
110 Ophthalmic Phacoemulsificat 886.4670 II MUS 2 C N
ion/
Phacofragmentat
ion Fluidic
----------------------------------------------------------------------------------------------------------------
111 Ophthalmic Phacofragmentati 886.4670 II HQC 1 N N
on Unit
----------------------------------------------------------------------------------------------------------------
112 Ortho Saw Blades 878.4820 I GFA, DWH, 1 C Y
GEY, GET
----------------------------------------------------------------------------------------------------------------
113 Ortho Surgical Drills 878.4820 I GEY, GET 1 C Y
----------------------------------------------------------------------------------------------------------------
114 Ortho Arthroscope 888.1100 II HRX 2 C Y
accessories
----------------------------------------------------------------------------------------------------------------
[[Page 38080]]
115 Ortho Bone Tap 888.4540 I HWX 1 C Y
----------------------------------------------------------------------------------------------------------------
116 Ortho Burr 888.4540 I HTT 1 C Y
----------------------------------------------------------------------------------------------------------------
117 Ortho Carpal Tunnel 888.4540 I LXH 2 C Y
Blade
----------------------------------------------------------------------------------------------------------------
118 Ortho Countersink 888.4540 I HWW 1 C Y
----------------------------------------------------------------------------------------------------------------
119 Ortho Drill Bit 888.4540 I HTW 1 C Y
----------------------------------------------------------------------------------------------------------------
120 Ortho Knife 888.4540 I HTS 1 C Y
----------------------------------------------------------------------------------------------------------------
121 Ortho Manual Surgical 888.4540 I LXH 1 C Y
Instrument
----------------------------------------------------------------------------------------------------------------
122 Ortho Needle Holder 888.4540 I HXK 1 C Y
----------------------------------------------------------------------------------------------------------------
123 Ortho Reamer 888.4540 I HTO 1 C Y
----------------------------------------------------------------------------------------------------------------
124 Ortho Rongeur 888.4540 I HTX 1 C Y
----------------------------------------------------------------------------------------------------------------
125 Ortho Scissors 888.4540 I HRR 1 C Y
----------------------------------------------------------------------------------------------------------------
126 Ortho Staple Driver 888.4540 I HXJ 1 C Y
----------------------------------------------------------------------------------------------------------------
127 Ortho Trephine 888.4540 I HWK 1 C Y
----------------------------------------------------------------------------------------------------------------
128 Ortho Flexible Reamers/ 886.4070 I GEY, HRG 1 C Y
Drills 878.4820
----------------------------------------------------------------------------------------------------------------
129 Ortho External 888.3040 II JEC, KTW, 2 N N
Fixation Frame 888.3030 KTT
----------------------------------------------------------------------------------------------------------------
130 Physical Non-Heating Lamp unclassifi ........ NHN 1 N N
Medicine for Adjunctive ed
Use Inpatient
Therapy
----------------------------------------------------------------------------------------------------------------
131 Physical Electrode Cable 890.1175 II IKD 1 N Y
Medicine
----------------------------------------------------------------------------------------------------------------
132 Physical External Limb 890.3420 I ISL 2 N Y
Medicine Component, Hip
Joint
----------------------------------------------------------------------------------------------------------------
133 Physical External Limb 890.3420 I ISY 2 N Y
Medicine Component, Knee
Joint
----------------------------------------------------------------------------------------------------------------
134 Physical External Limb 890.3420 I ISZ 2 N Y
Medicine Component,
Mechanical
Wrist
----------------------------------------------------------------------------------------------------------------
135 Physical External Limb 890.3420 I IQQ 2 N Y
Medicine Component,
Shoulder Joint
----------------------------------------------------------------------------------------------------------------
136 Plastic Stapler 878.4800 I GAG, GEF, 2 C Y
Surgery FHM, HBT
----------------------------------------------------------------------------------------------------------------
137 Radiology Isotope Needle 892.5730 II IWF 3 C N
----------------------------------------------------------------------------------------------------------------
138 Resp Endotracheal unclassifi III LNZ 3 C N
Tube Changer ed
----------------------------------------------------------------------------------------------------------------
139 Resp Anesthesia 868.5150 II BSP 3 C N
conduction
needle
----------------------------------------------------------------------------------------------------------------
140 Resp Short term 868.5150 II MIA 3 C N
spinal needle
----------------------------------------------------------------------------------------------------------------
141 Resp Respiratory 868.5240 I CAI 2 S Y
Therapy and
Anesthesia
Breathing
Circuits
----------------------------------------------------------------------------------------------------------------
142 Resp Oral and Nasal 868.5350 I BZB 1 C Y
Catheters
----------------------------------------------------------------------------------------------------------------
143 Resp Gas Masks 868.5550 I BSJ 1 S Y
----------------------------------------------------------------------------------------------------------------
144 Resp Breathing 868.5620 I BYP 1 N Y
Mouthpiece
----------------------------------------------------------------------------------------------------------------
[[Page 38081]]
145 Resp Tracheal Tube 868.5730 II BTR 3 C N
----------------------------------------------------------------------------------------------------------------
146 Resp Airway Connector 868.5810 I BZA 2 S Y
----------------------------------------------------------------------------------------------------------------
147 Resp CPAP Mask 868.5905 II BZD 3 S N
----------------------------------------------------------------------------------------------------------------
148 Resp Emergency Manual 868.5915 II BTM 2 S N
Resuscitator
----------------------------------------------------------------------------------------------------------------
149 Resp Tracheobronchial 868.6810 I BSY 3 S Y
Suction
Catheter
----------------------------------------------------------------------------------------------------------------
150 Surgery AC-Powered unclassifi ........ HWE 2 C N
Orthopedic ed
Instrument and
Accessories
----------------------------------------------------------------------------------------------------------------
151 Surgery Breast Implant unclassifi ........ MRD 1 C N
Mammary Sizer ed
----------------------------------------------------------------------------------------------------------------
152 Surgery Ultrasonic unclassifi ........ LFL 3 C N
Surgical ed
Instrument
----------------------------------------------------------------------------------------------------------------
153 Surgery Trocar 874.4420 I KAB, KBG, 3 C Y
KCI
----------------------------------------------------------------------------------------------------------------
154 Surgery Endoscopic 876.1500 II GCP, GCR 2 C N
Blades
----------------------------------------------------------------------------------------------------------------
155 Surgery Endoscopic 876.1500 II GCP, GCR 1 C N
Guidewires
----------------------------------------------------------------------------------------------------------------
156 Surgery Inflatable 878.3900 I FZF 1 N Y
External
Extremity
Splint
----------------------------------------------------------------------------------------------------------------
157 Surgery Noninflatable 878.3910 I FYH 1 N Y
External
Extremity
Splint
----------------------------------------------------------------------------------------------------------------
158 Surgery Catheter Needle 878.4200 I GCB 3 C Y
----------------------------------------------------------------------------------------------------------------
159 Surgery Implantable Clip 878.4300 II FZP 3 C N
----------------------------------------------------------------------------------------------------------------
160 Surgery Electrosurgical 878.4400 II BWA 2 C N
and Coagulation
Unit With
Accessories
----------------------------------------------------------------------------------------------------------------
161 Surgery Electrosurgical 878.4400 II HAM 2 C N
Apparatus
----------------------------------------------------------------------------------------------------------------
162 Surgery Electrosurgical 878.4400 II GEI 2 C N
Cutting and
Coagulation
Device and
Accessories
----------------------------------------------------------------------------------------------------------------
163 Surgery Electrosurgical 878.4400 II DWG 2 C N
Device
----------------------------------------------------------------------------------------------------------------
164 Surgery Electrosurgical 878.4400 II JOS 2 C N
Electrode
----------------------------------------------------------------------------------------------------------------
165 Surgery Implantable 878.4750 II GDW 3 C N
Staple, Clamp,
Clip for
Suturing
Apparatus
----------------------------------------------------------------------------------------------------------------
166 Surgery Percutaneous 878.4800 I MJG 3 C Y
Biopsy Device
----------------------------------------------------------------------------------------------------------------
167 Surgery Gastro-Urology 878.4800 I FHR 3 C Y
Needle
----------------------------------------------------------------------------------------------------------------
168 Surgery Aspiration and 878.4800 I GAA 3 C Y
Injection
Needle
----------------------------------------------------------------------------------------------------------------
169 Surgery Biopsy Brush 878.4800 I GEE 1 C Y
----------------------------------------------------------------------------------------------------------------
170 Surgery Blood Lancet 878.4800 I FMK 1 C Y
----------------------------------------------------------------------------------------------------------------
171 Surgery Bone Hook 878.4800 I KIK 1 C Y
----------------------------------------------------------------------------------------------------------------
172 Surgery Cardiovascular 878.4800 I DWO 3 C Y
Biopsy Needle
----------------------------------------------------------------------------------------------------------------
173 Surgery Clamp 878.4800 I GDJ 1 C Y
----------------------------------------------------------------------------------------------------------------
174 Surgery Clamp 878.4800 I HXD 1 C Y
----------------------------------------------------------------------------------------------------------------
[[Page 38082]]
175 Surgery Curette 878.4800 I HTF 1 C Y
----------------------------------------------------------------------------------------------------------------
176 Surgery Disposable 878.4800 I KDC 1 C Y
Surgical
Instrument
----------------------------------------------------------------------------------------------------------------
177 Surgery Disposable Vein 878.4800 I GAJ 1 C Y
Stripper
----------------------------------------------------------------------------------------------------------------
178 Surgery Dissector 878.4800 I GDI 1 C Y
----------------------------------------------------------------------------------------------------------------
179 Surgery Forceps 878.4800 I GEN 2 C Y
----------------------------------------------------------------------------------------------------------------
180 Surgery Forceps 878.4800 I HTD 2 C Y
----------------------------------------------------------------------------------------------------------------
181 Surgery Gouge 878.4800 I GDH 1 C Y
----------------------------------------------------------------------------------------------------------------
182 Surgery Hemostatic Clip 878.4800 I HBT 2 C Y
Applier
----------------------------------------------------------------------------------------------------------------
183 Surgery Hook 878.4800 I GDG 1 C Y
----------------------------------------------------------------------------------------------------------------
184 Surgery Manual 878.4800 I MDM, MDW 1 C Y
Instrument
----------------------------------------------------------------------------------------------------------------
185 Surgery Manual Retractor 878.4800 I GZW 1 C Y
----------------------------------------------------------------------------------------------------------------
186 Surgery Manual Saw and 878.4800 I GDR, HAC 1 C Y
Accessories
----------------------------------------------------------------------------------------------------------------
187 Surgery Manual Saw and 878.4800 I HAC 1 C Y
Accessories
----------------------------------------------------------------------------------------------------------------
188 Surgery Manual Surgical 878.4800 I FZO 1 C Y
Chisel
----------------------------------------------------------------------------------------------------------------
189 Surgery Mastoid Chisel 878.4800 I JYD 1 C Y
----------------------------------------------------------------------------------------------------------------
190 Surgery Orthopedic 878.4800 I HTZ 1 C Y
Cutting
Instrument
----------------------------------------------------------------------------------------------------------------
191 Surgery Orthopedic 878.4800 I HXR 1 C Y
Spatula
----------------------------------------------------------------------------------------------------------------
192 Surgery Osteotome 878.4800 I HWM 1 C Y
----------------------------------------------------------------------------------------------------------------
193 Surgery Rasp 878.4800 I GAC 1 C Y
----------------------------------------------------------------------------------------------------------------
194 Surgery Rasp 878.4800 I HTR 1 C Y
----------------------------------------------------------------------------------------------------------------
195 Surgery Retractor 878.4800 I GAD 1 C Y
----------------------------------------------------------------------------------------------------------------
196 Surgery Retractor 878.4800 I HXM 1 C Y
----------------------------------------------------------------------------------------------------------------
197 Surgery Saw 878.4800 I HSO 1 C Y
----------------------------------------------------------------------------------------------------------------
198 Surgery Scalpel Blade 878.4800 I GES 1 C Y
----------------------------------------------------------------------------------------------------------------
199 Surgery Scalpel Handle 878.4800 I GDZ 1 C Y
----------------------------------------------------------------------------------------------------------------
200 Surgery Scissors 878.4800 I LRW 1 C Y
----------------------------------------------------------------------------------------------------------------
201 Surgery Snare 878.4800 I GAE 1 C Y
----------------------------------------------------------------------------------------------------------------
202 Surgery Spatula 878.4800 I GAF 1 C Y
----------------------------------------------------------------------------------------------------------------
203 Surgery Staple Applier 878.4800 I GEF 2 C Y
----------------------------------------------------------------------------------------------------------------
204 Surgery Stapler 878.4800 I GAG 2 C Y
----------------------------------------------------------------------------------------------------------------
205 Surgery Stomach and 878.4800 I FHM 2 C Y
Intestinal
Suturing
Apparatus
----------------------------------------------------------------------------------------------------------------
206 Surgery Surgical Curette 878.4800 I FZS 1 C Y
----------------------------------------------------------------------------------------------------------------
207 Surgery Surgical Cutter 878.4800 I FZT 1 C Y
----------------------------------------------------------------------------------------------------------------
208 Surgery Surgical Knife 878.4800 I EMF 1 S Y
----------------------------------------------------------------------------------------------------------------
209 Surgery Laser Powered 878.4810 II GEX 2 C N
Instrument
----------------------------------------------------------------------------------------------------------------
[[Page 38083]]
210 Surgery Ac-Powered Motor 878.4820 I GEY 2 C Y
----------------------------------------------------------------------------------------------------------------
211 Surgery Bit 878.4820 I GFG 1 C Y
----------------------------------------------------------------------------------------------------------------
212 Surgery Bur 878.4820 I GFF, GEY 1 C Y
----------------------------------------------------------------------------------------------------------------
213 Surgery Cardiovascular 878.4820 I DWH 1 C Y
Surgical Saw
Blade
----------------------------------------------------------------------------------------------------------------
214 Surgery Chisel 878.4820 I KDG 1 C Y
(Osteotome)
----------------------------------------------------------------------------------------------------------------
215 Surgery Dermatome 878.4820 I GFD 1 C Y
----------------------------------------------------------------------------------------------------------------
216 Surgery Electrically 878.4820 I DWI 2 C Y
Powered Saw
----------------------------------------------------------------------------------------------------------------
217 Surgery Pneumatic 878.4820 I GET 2 C Y
Powered Motor
----------------------------------------------------------------------------------------------------------------
218 Surgery Pneumatically 878.4820 I KFK 2 C Y
Powered Saw
----------------------------------------------------------------------------------------------------------------
219 Surgery Powered Saw and 878.4820 I HAB 2 C Y
Accessories
----------------------------------------------------------------------------------------------------------------
220 Surgery Saw Blade 878.4820 I GFA 1 C Y
----------------------------------------------------------------------------------------------------------------
221 Surgery Nonpneumatic 878.5900 I GAX 1 N Y
Tourniquet
----------------------------------------------------------------------------------------------------------------
222 Surgery Pneumatic 878.5910 I KCY 1 N Y
Tourniquet
----------------------------------------------------------------------------------------------------------------
223 Surgery Endoscopic 888.4540 I HXJ 2 C Y
Staplers
----------------------------------------------------------------------------------------------------------------
224 Surgery Trocar 876.1500 II GCJ, DRC 3 C N
870.1390
----------------------------------------------------------------------------------------------------------------
225 Surgery Surgical Cutting 878.4800 I GDZ, GDX, 2 C Y
Accessories 874.4420 GES, KBQ,
KAS
----------------------------------------------------------------------------------------------------------------
226 Surgery Electrosurgical 876.4300 II HAM, GEI, 2 C N
Electrodes/ 878.4400 FAS
Handles/Pencils
----------------------------------------------------------------------------------------------------------------
227 Surgery Scissor Tips 878.4800 I LRW, HDK, 2 C Y
884.4520 HDJ, JZB,
874.4420 KBD
----------------------------------------------------------------------------------------------------------------
228 Surgery Laser Fiber 878.4810 II GEX, EWG, 1 C N
Delivery 874.4500 LLW, HQF,
Systems 886.4390 HHR, HQB
884.4550
886.4690
----------------------------------------------------------------------------------------------------------------
\1\ N means no.
\2\ Y means yes.
[dagger] Indicates a change since last publication.
Dated: June 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16109 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S