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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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SurgiCase Online
Materialise NV
SurgiCase Online
In Commercial Distribution

  • E314SURGICASEONLINE0 ()
SurgiCase Online

  • CAD/CAM software
GEISINGER WYOMING VALLEY MANI
MEDLINE INDUSTRIES, INC.
VASC1331
In Commercial Distribution

  • 40195327141999 ()
  • 10195327141998 ()
VASC1331

  • General surgical procedure kit, non-medicated, single-use
10M - Wyoming Body Fluid
Certified Safety Manufacturing, Inc.
FK204-903
In Commercial Distribution

  • 00766588049038 ()
FK204-903

  • First aid kit, medicated
Wyoming BFK+ - 10 Refill
Certified Safety Manufacturing, Inc.
FKR204-903
In Commercial Distribution

  • 00766588047034 ()
FKR204-903

  • First aid kit, medicated
ProPlan CMF Online
Materialise NV
ProPlan CMF Online
In Commercial Distribution

  • E314PROPLANCMFONLINE0 ()
ProPlan CMF Online

  • CAD/CAM software
MTO PROTECTION STATION KIT WYOMING
MEDLINE INDUSTRIES, INC.
65130563
In Commercial Distribution

  • 10193489061628 ()
65130563

  • Angiography kit
MTO LEFT HEART KIT GEISINGER WYOMING
MEDLINE INDUSTRIES, INC.
60070931
In Commercial Distribution

  • 20193489044246 ()
  • 10193489044249 ()
60070931

  • Angiography kit
MTO LEFT HEART KIT-GEISINGER WYOMING, PG
MEDLINE INDUSTRIES, INC.
65070931
In Commercial Distribution

  • 10193489060843 ()
65070931

  • Angiography kit
36PW Genesee & Wyoming Fleet - Poly White
Certified Safety Manufacturing, Inc.
K614-022
In Commercial Distribution

  • 00766588149226 ()
K614-022

  • Cardiopulmonary resuscitation mask, single-use
  • Dressing-fixation skin adhesive tape, non-silicone
  • Non-woven gauze pad
  • Endothermic cold therapy pack
  • First aid kit, medicated
  • Non-woven gauze roll/sheet
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • Non-rebreathing valve, single-use
16PW - Genesee & Wyoming RR - Poly White
Certified Safety Manufacturing, Inc.
K612-087
In Commercial Distribution

  • 00766588120874 ()
K612-087

  • Non-woven gauze pad
  • First aid kit, medicated
  • Dressing-fixation skin adhesive tape, non-silicone
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • Cardiopulmonary resuscitation mask, single-use
  • Adhesive bandage
  • Non-rebreathing valve, single-use
  • Non-woven gauze roll/sheet
Zimmer online management system
Materialise NV
Zimmer online management system
Not in Commercial Distribution

  • E314ZIMMERPSIOMS0 ()
Zimmer online management system

  • CAD/CAM software
Signature online management system
Materialise NV
Signature online management system
Not in Commercial Distribution

  • E314SIGNATUREOMS0 ()
Signature online management system

  • CAD/CAM software
Lexie Lumen Duo Silver - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Silver
In Commercial Distribution

  • 00850022464171 ()
LLO00004SL

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution

  • 00860003469866 ()
LLO00002BR

  • Air-conduction hearing aid, receiver-in-canal
I-neb Insight Online Multi-Lang Assembly
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
Not in Commercial Distribution

  • 00383730001005 ()
1100081

  • Ultrasonic nebulizing system
Go Prime - Black - WAG Online
HEARX GROUP (PTY) LTD
Go Hearing
Not in Commercial Distribution

  • 00810153660040 ()
GHPS00003BL

  • Air-conduction hearing aid, in-the-ear
Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
LB1001
In Commercial Distribution

Online

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution

  • 00860003469880 ()
LLO00002MB

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Light Gray - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Light Gray
In Commercial Distribution

  • 00860003469842 ()
LLO00002GR

  • Air-conduction hearing aid, receiver-in-canal
Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software
Lexie Lumen OTC Hearing Aids - Beige Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Beige
In Commercial Distribution

  • 00850022464157 ()
LLO00003BE

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen OTC Hearing Aids - Gray Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Gray
In Commercial Distribution

  • 00850022464065 ()
LLO00001GR

  • Air-conduction hearing aid, receiver-in-canal
Lexie B2 Plus Powered by Bose-WAG Online
HEARX GROUP (PTY) LTD
Lexie Hearing
In Commercial Distribution

  • 00810153660033 ()
LBS00002B2PLS

  • Air-conduction hearing aid, receiver-in-canal
Go Hearing - Go Ultra - Gray - BTE - WAG Online
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online
In Commercial Distribution

  • 00810153660057 ()


  • Air-conduction hearing aid, behind-the-ear
Basin wrap 50"x76" 2.25m;on-line lam, 1170pc/glrd
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080562 ()
  • 00683534080566 ()
BW50076-1

  • Medical equipment/instrument drape, single-use
Basin wrap 50"x50" 2.25m;on-line lam,1800pc/G
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080555 ()
  • 00683534080559 ()
BW50050-1

  • Medical equipment/instrument drape, single-use
Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online - CASE
In Commercial Distribution

  • 10810153660054 ()
GHUS00002CA

  • Air-conduction hearing aid, behind-the-ear
HPLC Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38910
In Commercial Distribution

  • 04250317523822 ()

  • 1 pcs.
38910

  • High performance liquid chromatography analyser column IVD
Trap Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38920
In Commercial Distribution

  • 04250317523761 ()

  • 1 pcs.
38920

  • High performance liquid chromatography analyser column IVD
No Description
Roche Diagnostics GmbH
3531066190
Not in Commercial Distribution

  • 04015630997169 ()
3531066190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
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