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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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Cryostore - 10816203020298

Cryostore 1950 EVA Freezing Bag, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1950aY8SW
Not in Commercial Distribution

  • 10816203020298 ()
  • 20816203020295 ()


  • Blood/tissue storage/culture container

CryoSC-Db Freezing Bag - 07640125650402

No Description
Biosafe S.A.
FB-100.2b
Not in Commercial Distribution

  • 07640125650419 ()
  • 07640125650402 ()
10041

  • Blood/tissue storage/culture container

CryoSC-D Freezing Bag - 07640125650389

No Description
Biosafe S.A.
FB-100.2
Not in Commercial Distribution

  • 7640125650396 ()
  • 07640125650389 ()
10032

  • Blood/tissue storage/culture container

CryoSC-S Freezing Bag - 07640125650365

No Description
Biosafe S.A.
FB-100.1
Not in Commercial Distribution

  • 07640125650372 ()
  • 07640125650365 ()
10023

  • Blood/tissue storage/culture container

Precise Sapphire - M896PRSAP0600

Precise Sapphire - 60 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-060
In Commercial Distribution

  • M896PRCSAP0601 ()
  • M896PRSAP0600 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Sapphire - M896PRCSAP1200

Precise Sapphire - 120 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-120
In Commercial Distribution

  • M896PRCSAP1201 ()
  • M896PRCSAP1200 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Diamond - M896PRCDIA1200

Precise Diamond - 120 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-120
In Commercial Distribution

  • M896PRCDIA1201 ()
  • M896PRCDIA1200 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Diamond - M896PRCDIA0600

Precise Diamond - 60 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-060
In Commercial Distribution

  • M896PRCDIA0600 ()
  • M896PRCDIA0601 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise - M896AMS500350560

Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-056
In Commercial Distribution

  • M896AMS500350560 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise - M896AMS500350530

Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-053
In Commercial Distribution

  • M896AMS500350530 ()


  • Haematological concentrate system preparation kit, platelet concentration
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