FDA UDI
In Commercial Distribution
🇺🇸 United States
Epicel (cultured epidermal autografts)
DI: W41020AU201S1969
·
Model: N/A
·
VERICEL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epicel (cultured epidermal autografts)
- Primary DI
- W41020AU201S1969
- Version / Model
- N/A
- Company Name
- VERICEL CORPORATION
- Labeler DUNS
- 079745570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-05
- Public Version
- 1
- Public Version Date
- 2024-02-13
- Public Version Status
- New
- Public Device Record Key
- e062635a-2a0e-4797-a134-4300dec9b2ab
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 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.
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
- No
- 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 | W41020AU201S1969 | 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, or the graft dish has a broken seal or appears cloudy..
- 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).
- 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
- Inspect the self-seal bags that contain Epicel grafts for media leaks. If a self-seal bag contains media, then inspect each graft dish in the bag for broken seal or damage prior to use.