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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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IH-Com Kit Fullversion US; Software Version: 04.0.27.
Bio-Rad Medical Diagnostics GmbH
04.0.27
In Commercial Distribution

  • 03610520569870 ()
009100

  • Laboratory instrument/analyser application software IVD
Geenius HIV 1/2 Controls
BIO-RAD
72339
In Commercial Distribution

  • 03610520013854 ()


  • HIV1/HIV2 antibody IVD, control
Geenius HIV 1/2 Supplemental assay
BIO-RAD
72461
In Commercial Distribution

  • 03610520013847 ()
72461

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label
Nuo Therapeutics, Inc.
AGWR-04
In Commercial Distribution

  • 10852714003153 ()


  • Wound dressing kit, medicated
Aurix Eight Pack Kit Case of 8 Wound Dressing Kits and 8 Reagent Kits with 010512 Aurix Eight Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-08
In Commercial Distribution

  • 10852714003146 ()


  • Wound dressing kit, medicated
Aurix Five Pack Kit Case of 5 Wound Dressing Kits and 5 Reagent Kits with 010503 Aurix Five Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-05
In Commercial Distribution

  • 10852714003139 ()


  • Wound dressing kit, medicated
Aurix Single Pack Kit Single Kit with 010405 Aurix Single Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-01
In Commercial Distribution

  • 10852714003122 ()


  • Wound dressing kit, medicated
Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution

  • 10852714003108 ()


  • Wound dressing kit, medicated
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution

  • 20852282007147 ()
  • 10852282007140 ()
  • 00852282007143 ()
7201-50

  • Medical product temperature point indicator, thermochemical
No Description
Thermo Electron LED GmbH
CW3 Cell Washer
Not in Commercial Distribution

  • 10850685007002 ()
75007504

  • Cell washer IVD
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