Identity
- Trade Name
- RECELL FDA UDI
- Generic Name
- Autologous skin cell grafting kit FDA UDI
- Device Name
- RECELL Autologous Cell Harvesting Device FDA UDI
- Model / Reference
- US 480 FDA UDI
- Description
- RECELL Autologous Cell Harvesting Device FDA UDI
Identifiers
- Catalog Number
- AVRL0102 FDA UDI
- Primary DI / UDI-DI
- 00851707004262 FDA UDI
- FDA Product Code
- QWY FDA UDI
- GMDN Term
- Autologous skin cell grafting kit FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Autologous skin cell grafting kit
Recell by AVITA Medical Americas, LLC — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- AVITA Medical Americas, LLC
Sources (2)
- FDA UDI 2528c2c7-8f09-47a4-aa3e-36bba2621ec5 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026