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No Description
Biosafe S.A.
FB-100.2b
Not in Commercial Distribution
- 07640125650419 ()
- 07640125650402 ()
10041
- Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.2
Not in Commercial Distribution
- 7640125650396 ()
- 07640125650389 ()
10032
- Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.1
Not in Commercial Distribution
- 07640125650372 ()
- 07640125650365 ()
10023
- Blood/tissue storage/culture container
Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests.
MICRONICS, INC.
BT-101-025
In Commercial Distribution
- 00815312020000 ()
- 00815312020048 ()
BT-101-025
- ABO/Rh multiple blood grouping IVD, kit, agglutination
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area.
Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution
- W41020AU201S1969 ()
- Area/Surface Area: 50 Square centimeter
- Cultured skin autograft/xenograft
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 - 60 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-060
In Commercial Distribution
- M896PRCDIA0600 ()
- M896PRCDIA0601 ()
- Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-056
In Commercial Distribution
- M896AMS500220560 ()
- Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-050
In Commercial Distribution
- M896AMS500220500 ()
- Haematological concentrate system preparation kit, platelet concentration
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