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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Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2004
Not in Commercial Distribution

  • 20811137010626 ()
  • 10811137010629 ()
  • 0FE04R2004 ()
  • 00811137010622 ()
4R2004

  • Blood/tissue storage/culture container
Transfer Pack Container 600 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2023
Not in Commercial Distribution

  • 20811137010633 ()
  • 10811137010636 ()
  • 0FE04R2023 ()
  • 00811137010639 ()
4R2023

  • Blood/tissue storage/culture container
Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2001
Not in Commercial Distribution

  • 20811137010619 ()
  • 10811137010612 ()
  • 0FE04R2001 ()
  • 00811137010615 ()
4R2001

  • Blood/tissue storage/culture container
Transfer Pack Container 600 mL with Male Luer Adapter. Sterile Fluid Path
FENWAL, INC.
4R2024
Not in Commercial Distribution

  • 0FE04R2024 ()
  • 10811137010551 ()
  • 00811137010554 ()
  • 20811137010558 ()
4R2024

  • Blood/tissue storage/culture container
Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2014
Not in Commercial Distribution

  • 20811137010541 ()
  • 10811137010544 ()
  • 0FE04R2014 ()
  • 00811137010547 ()
4R2014

  • Blood/tissue storage/culture container
Transfer Pack Container 1000 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2032
Not in Commercial Distribution

  • 20811137010497 ()
  • 10811137010490 ()
  • 0FE04R2032 ()
  • 00811137010493 ()
4R2032

  • Blood/tissue storage/culture container
Red Cell Freezing Pack 2000 mL. Sterile Fluid Path
FENWAL, INC.
4R2422
Not in Commercial Distribution

  • 10811137010766 ()
  • 00811137010769 ()
  • 0FE04R2422 ()
4R2422

  • Blood/tissue storage/culture container
Transfer Pack Container 600 mL with 8 couplers. Sterile Fluid Path
FENWAL, INC.
4R2027
Not in Commercial Distribution

  • 10811137010735 ()
  • 00811137010738 ()
  • 0FE04R2027 ()
4R2027

  • Blood/tissue storage/culture container
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
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 approximately 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
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
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