DEVICE: Epicel (cultured epidermal autografts) (W41020AU201P0001)
Device Identifier (DI) Information
Epicel (cultured epidermal autografts)
0
In Commercial Distribution
VERICEL CORPORATION
0
In Commercial Distribution
VERICEL CORPORATION
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61662 | 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 |
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OCE | Cultured Epithelial Autograft |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BH990200 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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). |
Clinically Relevant Size
[?]Size Type Text |
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Area/Surface Area: 50 Square centimeter |
Device Record Status
33657e60-9a91-44f8-b276-ab41b96d8b77
March 17, 2021
4
November 17, 2017
March 17, 2021
4
November 17, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-232-7546
customercare@vcel.com
customercare@vcel.com