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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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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

PMT® CORPORATION HALO - 00650551045830

TRACTION BAIL WITH HEADBLOCK ATTACHMENT HARDWARE
PMT CORPORATION
1206-13
In Commercial Distribution

  • 00650551045830 ()
1206-13

  • Cervical spine immobilization system, single-use

Dako Omnis Clean Liquid System Hardware - 05700575014017

Dako Omnis Clean Liquid System Hardware
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
GC122
In Commercial Distribution

  • 05700575014017 ()

  • Pcs


  • Microscope slide stainer IVD

Protekt Parts - 05060488573446

Universal Calf Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RCP
In Commercial Distribution

  • 05060488573446 ()

  • Height: 4 Inch
  • Length: 8 Inch
  • Width: 2 Inch
PP-RCP

  • Wheelchair armrest

Spex Limited - 09420051796102

Depth Extension Kit, Back Support Hardware
SPEX LIMITED
1259-2453-100
In Commercial Distribution

  • 09420051796102 ()


  • Wheelchair back rest

Spex Limited - 09420051745582

Quad-Mount fixed hardware for back support.
SPEX LIMITED
1259-2470-100
In Commercial Distribution

  • 09420051745582 ()


  • Wheelchair back rest

Spex Limited - 09420051745575

Spex Back Support Dual Mount Hardware
SPEX LIMITED
1259-2200-100
In Commercial Distribution

  • 09420051745575 ()


  • Wheelchair back rest

Spex Limited - 09420051709881

Spex Back Support Single Mount Hardware
SPEX LIMITED
1259-2100-100
In Commercial Distribution

  • 09420051709881 ()


  • Wheelchair back rest

Spex - 09420051709607

Spex Back Support Quad Mount Hardware
SPEX LIMITED
1259-2400-100
In Commercial Distribution

  • 09420051709607 ()
1259-2400-100

  • Wheelchair back rest

Broken Screw Removal Instruments - 00840194480772

Plate & Screw Hardware Removal, Lower Tray
ORTHOPEDIATRICS CORP.
01-9200-5003
In Commercial Distribution

  • 00840194480772 ()
01-9200-5003

  • Instrument tray, reusable

MAXFRAME - 10886982306470

MAXFRAME(TM) IMPLANTS/ LINEAR STRUTS & HARDWARE
Synthes GmbH
61.313.001
In Commercial Distribution

  • 07612334224583 ()
  • 10886982306470 ()
61313001

  • Surgical instrument/implant rack

CONMED - 10845854041574

HARDWARE KIT FOR 14"/17" SHELF
Conmed Corporation
VP8569
In Commercial Distribution

  • 10845854041574 ()
VP8569

  • Medical device integration rack

Portrait HUBXB - 00195278713193

Portrait Mobile Patient Monitor Hardware HUBXB
GE Healthcare Finland Oy
HUBXB
In Commercial Distribution

  • 00195278713193 ()
5923524

  • Wearable multiple vital physiological parameter monitor

AADCO - 00840348503654

GUERBET HARDWARE KIT, CEILING COLUMN ASSEMBLY
AADCO MEDICAL, INC.
OSP-241436S
In Commercial Distribution

  • 00840348503654 ()
OSP-241436S

  • Custom-made medical device mount

AADCO - 00840348503548

GUERBET HARDWARE KIT, MRI-SAFE ANCHORAGE PLATE
AADCO MEDICAL, INC.
OSP-241416S
In Commercial Distribution

  • 00840348503548 ()
OSP-241416S

  • Custom-made medical device mount

MEDRAD® MRXperion MR Injection System - 00616258008165

"Hand switch with mounting hardware (85276557)"
BAYER MEDICAL CARE INC.
SSMR START
In Commercial Distribution

  • 00616258008165 ()
SSMR START

  • Contrast medium injection system hand controller kit

Drive - 00822383268927

Headrest Hardware, Kanga, 1 set/ea
Drive Devilbiss Healthcare
KG 1011
In Commercial Distribution

  • 00822383268927 ()


  • Wheelchair/chair/stander headrest

Probasics - 00815067013098

K4 Deluxe Amputee Adapter Hardware Included
COMPASS HEALTH BRANDS CORP.
X1WC4DAM03
In Commercial Distribution

  • 00815067013098 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013074

K4 Deluxe Super-Hemi Kit Hardware Included
COMPASS HEALTH BRANDS CORP.
X1WC4DAM01
In Commercial Distribution

  • 00815067013074 ()


  • Push-rim manual wheelchair, non-bariatric

LEVEL ONE - 00888118092427

SIDE RAIL, GREY, FEMALE, W/HARDWARE
KLS-Martin L.P.
99-962-57-04
In Commercial Distribution

  • 00888118092427 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092410

SIDE RAIL, PURPLE, FEMALE, W/HARDWARE
KLS-Martin L.P.
99-962-56-04
In Commercial Distribution

  • 00888118092410 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092359

SIDE RAIL, GREY, MALE, W/HARDWARE
KLS-Martin L.P.
99-962-47-04
In Commercial Distribution

  • 00888118092359 ()


  • Surgical instrument/implant rack

LEVEL ONE - 00888118092342

SIDE RAIL, PURPLE, MALE, W/HARDWARE
KLS-Martin L.P.
99-962-46-04
In Commercial Distribution

  • 00888118092342 ()


  • Surgical instrument/implant rack

Integra® - 10381780542292

Integra® Hardware Kit for UCHR
INTEGRA LIFESCIENCES CORPORATION
UCHRHK
In Commercial Distribution

UCHRHK

  • Stereotactic radiosurgical invasive head frame

Integra® - 10381780252443

Integra® Hardware Kit for UCHR
INTEGRA LIFESCIENCES CORPORATION
UCHRHK
In Commercial Distribution

  • M248UCHRHK1 ()
  • 10381780252443 ()
UCHRHK

  • Stereotactic radiosurgical invasive head frame

AtriCure System Cart - 00818354016444

ASCB Installation Tools and Hardware Kit
ATRICURE, INC.
ASCB
In Commercial Distribution

  • 00818354016444 ()
A000810

  • Instrument trolley

SMART TSF - 00885556746271

SMART TSF HARDWARE TRAY HALF SIZE
Smith & Nephew, Inc.
71075503
In Commercial Distribution

  • 00885556746271 ()
71075503

  • Instrument tray, reusable

UA Win10 Kit - 15099590735982

Urinalysis Win10 Kit with PC7 hardware
BECKMAN COULTER IRELAND INC.
C52900
In Commercial Distribution

  • 15099590735982 ()
C52900

  • Urine analyser IVD, laboratory

Dimensions - 15420045512641

Contrast Enhanced Digital Mammography Imaging Kit
Hologic, Inc.
CEDM Hardware Kit
In Commercial Distribution

  • 15420045512641 ()
ASY-14055

  • Stationary mammographic x-ray system, digital

Prone Breast, Hardware Kit, Threaded Indexing Pegs - 00714646001436

Prone Breast, Hardware Kit, Threaded Indexing Pegs
Bionix, LLC
PBRT-6301
In Commercial Distribution

  • 00714646001436 ()
PBRT-6301

  • Radiological whole-body positioner

Active Heel Traction Boot - 03596010656353

KIT AHTB RETRFIT HARDWARE WELL LEG HOLDR
Smith & Nephew, Inc.
72203315
In Commercial Distribution

  • 03596010656353 ()
72203315

  • Traction boot

Active Heel Traction Boot - 03596010656346

KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR
Smith & Nephew, Inc.
72203272
In Commercial Distribution

  • 03596010656346 ()
72203272

  • Traction boot

AADCO - 00840348503623

GUERBET HARDWARE KIT, GROUND WIRES & MOUNTING SCREWS
AADCO MEDICAL, INC.
OSP-241424S
In Commercial Distribution

  • 00840348503623 ()
OSP-241424S

  • Custom-made medical device mount

AADCO - 00840348503616

GUERBET HARDWARE KIT, PLASTIC COVERS, SPRING ARM
AADCO MEDICAL, INC.
OSP-241423S
In Commercial Distribution

  • 00840348503616 ()
OSP-241423S

  • Custom-made medical device mount

AADCO - 00840348503609

GUERBET HARDWARE KIT, PLASTIC COVERS, EXTENSION ARM
AADCO MEDICAL, INC.
OSP-241422S
In Commercial Distribution

  • 00840348503609 ()
OSP-241422S

  • Custom-made medical device mount

AADCO - 00840348503579

GUERBET HARDWARE KIT, CEILING SUSPENSION SYSTEM (OSP-10-G3-H)
AADCO MEDICAL, INC.
OSP-241419S
In Commercial Distribution

  • 00840348503579 ()
OSP-241419S

  • Custom-made medical device mount

NA - 07613327053104

Sterilization Tray for Arthroscopy Access Hardware XL
STRYKER CORPORATION
0295800200
In Commercial Distribution

  • 07613327053104 ()
0295800200

  • Device sterilization/disinfection container, reusable

NA - 07613327051476

Sterilization Tray for Autoclavable Endoscope and Hardware
STRYKER CORPORATION
0233032116
In Commercial Distribution

  • 07613327051476 ()
0233032116

  • Device sterilization/disinfection container, reusable

Probasics - 00815067013289

K4 Deluxe Wheel Locks, Pair w/ Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM16
In Commercial Distribution

  • 00815067013289 ()


  • Push-rim manual wheelchair, non-bariatric
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