Identity
- Trade Name
- Epicel (cultured epidermal autografts) FDA UDI
- Generic Name
- Cultured skin autograft/xenograft FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- W41020AU201P0001 FDA UDI
- FDA Product Code
- OCE FDA UDI
- GMDN Term
- Cultured skin autograft/xenograft FDA UDI
Classification
- Device Class
- Unclassified FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 50 Square centimeter FDA UDI
Category: Cultured skin autograft/xenograft
Epicel (cultured epidermal autografts) by Vericel Corporation — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cultured skin autograft/xenograft.
- Epicel (cultured epidermal autografts) — Vericel Corporation · Unclassified
Cleared under the same submission
BH990200 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class Unclassified | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vericel Corporation
Sources (1)
- FDA UDI 33657e60-9a91-44f8-b276-ab41b96d8b77 37 fields · synced May 30, 2026