DEVICE: Epicel (cultured epidermal autografts) (W41020AU201P0001)

Device Identifier (DI) Information

Epicel (cultured epidermal autografts)
0
In Commercial Distribution

VERICEL CORPORATION
W41020AU201P0001
ICCBBA

1
079745570 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
Yes

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cultured skin autograft/xenograft A non-sterile tissue, in vitro cultivated from cells of human and animal origin, intended to cover skin wounds typically resulting from a burn injury. It is developed by ex vivo aseptic processing of a biopsy of skin from the recipient, involving enzymatic digestion and multiplication (culture) of epidermal cells combined with proliferation-arrested, murine (mouse) fibroblasts, to produce a graft of sufficient size for wound coverage. It is typically supplied by attachment to a gauze backing and may be used alone or in conjunction with split-thickness skin autografts.
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FDA Product Code

[?]
Product Code Product Code Name
OCE Cultured Epithelial Autograft
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BH990200 0
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 13 and 23 Degrees Celsius
Storage Environment Temperature: between 55 and 73 Degrees Fahrenheit
Special Storage Condition, Specify: Inspect the Epicel packaging and ensure that it is intact. Do not use Epicel if package is opened or damaged.
Special Storage Condition, Specify: Store Epicel in the original shipping container in which it is received. Do not remove from original shipping container until ready for use.
Special Storage Condition, Specify: Keep Epicel out of the operating room until ready for application
Special Storage Condition, Specify: Inspect the medium in which Epicel is transported. Do not use an Epicel graft if the medium appears cloudy.
Special Storage Condition, Specify: Do not store in a refrigerator or freezer. Do not refrigerate, freeze, or incubate the Epicel shipping container or its contents. Do not reuse, freeze, refrigerate, or sterilize Epicel after opening.
Special Storage Condition, Specify: Maintain the shipping carton closed and at cool room temperature (13 to 23°C, 55 to 73°F).
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Clinically Relevant Size

[?]
Size Type Text
Area/Surface Area: 50 Square centimeter
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Device Record Status

33657e60-9a91-44f8-b276-ab41b96d8b77
March 17, 2021
4
November 17, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
Yes CLOSE

Customer Contact

[?]
1-800-232-7546
customercare@vcel.com
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