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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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No Description
Regenlab USA LLC
RK-BCT-3
Not in Commercial Distribution

  • 08500331310066 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Regenlab USA LLC
RK-BCT-1
Not in Commercial Distribution

  • 08500331310042 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Regenlab USA LLC
A-CP-3
Not in Commercial Distribution

  • 08500331310011 ()


  • Haematological concentrate system preparation kit, platelet concentration
Hematype Segment Device
Fresenius Kabi AG
4R5128
In Commercial Distribution

  • 20810020440533 ()
  • 10810020440536 ()
  • 00810020440539 ()
4R5128

  • Blood collection tube holder, single-use
Blood mixing and weighing device
Transmed Medizintechnik GmbH & Co. KG
TRANSWAAG PRO
In Commercial Distribution

  • 04028339620139 ()
97.8700.105

  • Blood weighing scale
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
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