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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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Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit
Nuo Therapeutics, Inc.
AUXP-4TR
In Commercial Distribution

  • 00852714003248 ()


  • Wound dressing kit, medicated
Aurix Reagent Kit Single Kit with 010110 Reagent Kit Label
Nuo Therapeutics, Inc.
AGSR-03
In Commercial Distribution

  • 00852714003118 ()


  • Wound dressing kit, medicated
Aurix Wound Dressing Kit Single Unit (Kit or Tray) with 010364 Tyvek Lidstock Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution

  • 00852714003101 ()


  • Wound dressing kit, medicated
Aurix Centrifuge with 010463 Aurix Centrifuge Machine Registration Label
Nuo Therapeutics, Inc.
AGSC-04
In Commercial Distribution

  • 00852714003095 ()


  • General-purpose centrifuge IVD
Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
90-1019
In Commercial Distribution

  • 00686597010198 ()
90-1019

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Plasma Thawing System
CYTOTHERM LP
CT-D1
In Commercial Distribution

  • 00861128000354 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-DR
In Commercial Distribution

  • 00861128000347 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-D4
In Commercial Distribution

  • 00861128000330 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4T.6C
In Commercial Distribution

  • 00861128000323 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4T
In Commercial Distribution

  • 00861128000316 ()


  • Cryopreserved blood/tissue thawing unit
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