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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OrthoPediatrics Hardware Removal - 00840194465212

Driver, Cannulated 3.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0130
In Commercial Distribution

  • 00840194465212 ()
01-9200-0130

  • Surgical screwdriver, reusable

OrthoPediatrics Hardware Removal - 00840194465205

Driver, Solid 3.0mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0030
In Commercial Distribution

  • 00840194465205 ()
01-9200-0030

  • Surgical screwdriver, reusable

OrthoPediatrics Hardware Removal - 00840194465199

Driver, Cannulated 2.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0125
In Commercial Distribution

  • 00840194465199 ()
01-9200-0125

  • Surgical screwdriver, reusable

OrthoPediatrics Hardware Removal - 00840194465182

Driver, Solid 2.5mm Hex
ORTHOPEDIATRICS CORP.
01-9200-0025
In Commercial Distribution

  • 00840194465182 ()
01-9200-0025

  • Surgical screwdriver, reusable

OrthoPediatrics Hardware Removal - 00840194465168

Driver, Solid T20
ORTHOPEDIATRICS CORP.
01-9200-0020
In Commercial Distribution

  • 00840194465168 ()
01-9200-0020

  • Surgical screwdriver, reusable

OrthoPediatrics Hardware Removal - 00840194465151

Driver, Cannulated T15
ORTHOPEDIATRICS CORP.
01-9200-0115
In Commercial Distribution

  • 00840194465151 ()
01-9200-0115

  • Surgical screwdriver, reusable

OrthoPediatrics Hardware Removal - 00840194465144

Driver, Solid T15
ORTHOPEDIATRICS CORP.
01-9200-0015
In Commercial Distribution

  • 00840194465144 ()
01-9200-0015

  • Surgical screwdriver, reusable

OrthoPediatrics Hardware Removal - 00840194465137

Driver, Solid T10
ORTHOPEDIATRICS CORP.
01-9200-0010
In Commercial Distribution

  • 00840194465137 ()
01-9200-0010

  • Surgical screwdriver, reusable

Fixed Clip Hardware - 07540147000592

Fixed Clip hardware (pair) for use with Matrx-Vi and Matrx Kidabra-Vi Base Cushions. Fixed Hardware used to secure the drop hook hardware to the seat fame.
Motion Concepts Inc
BFC
In Commercial Distribution

  • 07540147000592 ()
BFC

  • Wheelchair back rest positioner

Split Mounting Hardware - 07540147000219

Split Mounting Hardware (pair). (Fits 3/4", 7/8" and 1" back canes). Optional mounting hardware for use with standard Matrx PB and Elite backs. Allows clearance of back cane rigidizer bars/frame obstacles. Quick-release design.
Motion Concepts Inc
SMH
In Commercial Distribution

  • 07540147000219 ()
SMH

  • Wheelchair back rest positioner

Mini-Set Mounting Hardware - 07540147000189

Mini-Set Mounting Hardware (pair). Standard with Matrx Mini Backs. Quick-release design.
Motion Concepts Inc
MSMH
In Commercial Distribution

  • 07540147000189 ()
MSMH

  • Wheelchair back rest positioner

Easy-Set Mounting Hardware - 07540147000165

Easy-Set Mounting Hardware (pair). (Fits 3/4", 7/8" and 1" back canes). Standard hardware for Matrx Elite and PB Backs. Quick-release design.
Motion Concepts Inc
PBMH
In Commercial Distribution

  • 07540147000165 ()
PBMH

  • Wheelchair back rest positioner

MISCELLANEOUS HARDWARE MODULE - 00887868001468

No Description
Biomet Orthopedics, LLC
10283
In Commercial Distribution

  • 00887868001468 ()
10283

  • Instrument tray, reusable

Adstation™ - 00634782076993

ADSATION Wallboard,Small, w/hardware
AMERICAN DIAGNOSTIC CORP
5600S
In Commercial Distribution

  • 00634782076993 ()
5600S

  • Ophthalmic/otologic diagnostic set

Adstation™ - 00634782076344

ADSATION Wallboard,Large, w/hardware
AMERICAN DIAGNOSTIC CORP
5600
Not in Commercial Distribution

  • 00634782076344 ()
5600

  • Ophthalmic/otologic diagnostic set

Adstation™ - 00634782087661

ADSTATION Wallboard,Large, w/hardware
AMERICAN DIAGNOSTIC CORP
5602
In Commercial Distribution

  • 00634782087661 ()
5602

  • Ophthalmic/otologic diagnostic set

EX-M1 - 04547410448214

A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system

Pneumotrac - 05099169770508

6800 PNEUMOTRAC (HARDWARE ONLY)(1)
VITALOGRAPH (IRELAND) LIMITED
6800
In Commercial Distribution

  • 05099169770508 ()


  • Diagnostic spirometer, professional

AADCO - 00840348503555

GUERBET HARDWARE KIT, MRI-SAFE TRACK
AADCO MEDICAL, INC.
OSP-241417S
In Commercial Distribution

  • 00840348503555 ()
OSP-241417S

  • Custom-made medical device mount

FJ2000 System - 00889795131256

FJ-2000, Hardware for Fluid Bag
Paragon 28, Inc.
P65-002-0006
In Commercial Distribution

  • 00889795131256 ()
P65-002-0006

  • Surgical power tool system control unit, line-powered

Broselow - 10885403277696

Broselow&#8482 ALS Replacement Hardware
Carefusion Corporation
7730POCH
Not in Commercial Distribution

  • 50885403277694 ()
  • 10885403277696 ()
7730POCH

  • Cardiopulmonary resuscitation kit, single-use

CRW® - 10381780251927

CRW® Replacement Hardware Kit
INTEGRA LIFESCIENCES CORPORATION
CRWHK
Not in Commercial Distribution

  • M248CRWHK1 ()
  • 10381780251927 ()


  • Stereotactic radiosurgical invasive head frame

N/A - 04961333231072

TONGUE HARDWARE W/25 ARRAYS
PENTAX OF AMERICA, INC.
7124
In Commercial Distribution

  • 04961333231072 ()


  • Manometric gastrointestinal motility analysis system

NA - 20885556778801

SILICON STOPPER FOR HARDWARE RACK
Smith & Nephew, Inc.
71075521
In Commercial Distribution

  • 20885556778801 ()
  • 00885556778807 ()
71075521

  • Instrument tray, reusable

Vilex Tool - 00841132177891

Orthex Small Bone Hardware Tray
ORTHOPEDIATRICS CORP.
CFX-100
In Commercial Distribution

  • 00841132177891 ()
CFX-100

  • Instrument tray, reusable

Pneumotrac - 15099169777573

6800 PNEUMOTRAC HARDWARE ONLY US
VITALOGRAPH (IRELAND) LIMITED
6800
In Commercial Distribution

  • 05099169777576 ()
  • 15099169777573 ()


  • Diagnostic spirometer, professional

Pneumotrac - 15099169777320

6800 PNEUMOTRAC HARDWARE ONLY(1)
VITALOGRAPH (IRELAND) LIMITED
6800
In Commercial Distribution

  • 05099169777323 ()
  • 15099169777320 ()


  • Diagnostic spirometer, professional

NA - 00885556537565

ADJUSTABLE ARM BOARD HARDWARE KIT
Smith & Nephew, Inc.
72204749
In Commercial Distribution

  • 00885556537565 ()
72204749

  • Leg procedure positioner

SMART TSF - 00885556774847

SMART TSF HARDWARE INNER TRAY
Smith & Nephew, Inc.
71075504
In Commercial Distribution

  • 00885556774847 ()
71075504

  • Instrument tray, reusable

SPATIAL FRAME - 00885556013151

SPATIAL FRAME HARDWARE CASE LID
Smith & Nephew, Inc.
71070381
In Commercial Distribution

  • 00885556013151 ()
71070381

  • Instrument tray, reusable

FUKUDA DENSHI - 04538612916014

No Description
FUKUDA DENSHI CO.,LTD.
FP-908LP
In Commercial Distribution

  • 04538612916014 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612915154

No Description
FUKUDA DENSHI CO.,LTD.
FP-811
In Commercial Distribution

  • 04538612915154 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612916007

No Description
FUKUDA DENSHI CO.,LTD.
FP-908A
In Commercial Distribution

  • 04538612916007 ()


  • Software upgrade/unlocking key

Pure Vue - 10886705032204

Pure Vue Software expansion
Medos International Sàrl
242329
In Commercial Distribution

  • 10886705032204 ()
242329

  • Software upgrade/unlocking key

CHATTANOOGA - 00888912296533

CARD MULTIMEDIA DTS
DJO, LLC
2842
In Commercial Distribution

  • 00888912296533 ()


  • Software upgrade/unlocking key

BLUE LIGHT IMAGING UNIT - 04953170396021

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2305
In Commercial Distribution

  • 04953170396021 ()
N5769640

  • Software upgrade/unlocking key

Infrared imaging unit - 04953170395994

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
In Commercial Distribution

  • 04953170395994 ()


  • Software upgrade/unlocking key

AUTO FOCUS UNIT - 04953170395963

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2303
In Commercial Distribution

  • 04953170395963 ()


  • Software upgrade/unlocking key

UPGRADE KIT FOR UCES-3 (Version 4) - 04953170335464

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2051
Not in Commercial Distribution

  • 04953170335464 ()


  • Software upgrade/unlocking key

OTV-S500 UPGRADE PACK STROBE - 04953170458170

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2547
In Commercial Distribution

  • 04953170458170 ()
N6216940

  • Software upgrade/unlocking key
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