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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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Biotronix Healthcare Syringes - 00864085000405

Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
GE12085
In Commercial Distribution

  • 20864085000409 ()
  • 10864085000402 ()
  • 00864085000405 ()

  • Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
GE12085

  • Hypodermic needle, single-use
  • General-purpose syringe, single-use

CLS - 00864039000413

Saphenous Vein Cannula
COASTAL LIFE SYSTEMS, INC.
201006-000
In Commercial Distribution

  • 10864039000410 ()
  • 00864039000413 ()


  • Vascular irrigation cannula, cardiac vessel graft

Bernafon - 05711584084151

ZR7, KIT 312 2.4G NFM 90 L BE ZERENA 7
Bernafon AG
186013
In Commercial Distribution

  • 05711584084151 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584084113

ZR7, KIT 312 2.4G NFM 85 PB L BE ZERENA 7
Bernafon AG
186009
In Commercial Distribution

  • 05711584084113 ()


  • Air-conduction hearing aid, in-the-ear

DenSureFit - 00863995000109

DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.
OTC DENTAL CORPORATION
DSF212.00
In Commercial Distribution

  • 00863995000109 ()


  • Denture reliner, soft, home-use

TMM - NG/OG (Tactical Medical Module - Nasogastric/Orogastric) - 00863970000476

No Description
Altitude Technologies Inc.
5007
In Commercial Distribution

  • 00863970000476 ()


  • Nasogastric/orogastric tube

Bernafon - 05711584083994

ZR9, KIT 312 NFM 90 PB L BE ZERENA 9
Bernafon AG
185928
In Commercial Distribution

  • 05711584083994 ()


  • Air-conduction hearing aid, in-the-ear

Bernafon - 05711584083970

ZR9, KIT 312 NFM 90 L BE ZERENA 9
Bernafon AG
185926
In Commercial Distribution

  • 05711584083970 ()


  • Air-conduction hearing aid, in-the-ear

RNARetain - 00863840000285

No Description
ASURAGEN, INC.
84001
In Commercial Distribution

  • 00863840000285 ()
84001

  • General specimen container IVD, additive/medium

Bernafon - 05711584083956

ZR9, KIT 312 NFM 85 PB T L BE ZERENA 9
Bernafon AG
185924
In Commercial Distribution

  • 05711584083956 ()


  • Air-conduction hearing aid, in-the-ear
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