Epicel (cultured epidermal autografts)
Basic Information
- Brand Name
- Epicel (cultured epidermal autografts)
- Primary DI
- W41020AU201P0001
- Version / Model
- 0
- Company Name
- VERICEL CORPORATION
- Labeler DUNS
- 079745570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-17
- Public Version
- 4
- Public Version Date
- 2021-03-17
- Public Version Status
- Update
- Public Device Record Key
- 33657e60-9a91-44f8-b276-ab41b96d8b77
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCE | Cultured Epithelial Autograft | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | W41020AU201P0001 | ICCBBA |
Customer Contacts
- Phone
- 1-800-232-7546
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BH990200 | 0 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 50 | Square centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 13 – 23 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 55 – 73 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Inspect the Epicel packaging and ensure that it is intact. Do not use Epicel if package is opened or damaged.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Epicel in the original shipping container in which it is received. Do not remove from original shipping container until ready for use.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Epicel out of the operating room until ready for application
- Type
- Special Storage Condition, Specify
- Special Conditions
- Inspect the medium in which Epicel is transported. Do not use an Epicel graft if the medium appears cloudy.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Maintain the shipping carton closed and at cool room temperature (13 to 23°C, 55 to 73°F).