Identity
- Trade Name
- RECELL GO FDA UDI
- Generic Name
- Autologous skin cell grafting kit FDA UDI
- Device Name
- RECELL GO Autologous Cell Harvesting Device (Preparation Kit) FDA UDI
- Model / Reference
- AVRL0103 FDA UDI
- Description
- RECELL GO Autologous Cell Harvesting Device (Preparation Kit) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851707004286 FDA UDI
- FDA Product Code
- QCZ 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 Go by AVITA Medical Americas, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autologous skin cell grafting kit.
- RECELL — AVITA Medical Americas, LLC · Class III
- RECELL GO — AVITA Medical Americas, LLC · Class III
- RECELL GO mini — AVITA Medical Americas, LLC · Class III
- RECELL — AVITA Medical Americas, LLC · Class III
- RECELL — AVITA Medical Americas, LLC · Class III
Cleared under the same submission
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AVITA Medical Americas, LLC
Sources (1)
- FDA UDI 4d47b528-b983-4f29-bdbb-8a361a4e1629 34 fields · synced May 30, 2026