Identity
- Trade Name
- Restella FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
- Device Name
- Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. FDA UDI
- Model / Reference
- R20143-2020P FDA UDI
- Description
- Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421904065963 FDA UDI
- FDA Product Code
- FTL FDA UDIFTM FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
MR Safe FDA UDI
Restella by Aroa Biosurgery — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Aroa Biosurgery
Sources (1)
- FDA UDI 0ebc6026-c5e2-4bec-9929-3eb03a943b5e 36 fields · synced Jun 1, 2026