Identity
- Trade Name
- Skin Biopsy Transport Kit FDA UDI
- Generic Name
- Specimen container mailer, insulated FDA UDI
- Device Name
- The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile) FDA UDI
- Model / Reference
- 0 FDA UDI
- Description
- The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850037506207 FDA UDI
- FDA Product Code
- KDW FDA UDI
- GMDN Term
- Specimen container mailer, insulated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cell culture medium IVDSpecimen container mailer, insulated
Skin Biopsy Transport Kit by Vericel Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Vericel Corporation
Sources (1)
- FDA UDI 5c8c201c-6e7b-4eca-89bc-c86795d376db 35 fields · synced May 31, 2026