Identity
- Trade Name
- Solesta FDA UDI
- Generic Name
- Anal tissue reconstructive material FDA UDI
- Device Name
- Solesta injectable gel FDA UDI
- Model / Reference
- Gel 1.0 mL Syringe FDA UDI
- Description
- Solesta injectable gel FDA UDI
Identifiers
- Catalog Number
- 011506 FDA UDI
- Primary DI / UDI-DI
- 00850004725016 FDA UDI
- PMA Number
- P100014 FDA UDI
- FDA Product Code
- LNM FDA UDI
- GMDN Term
- Anal tissue reconstructive material 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
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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Anal tissue reconstructive material
Solesta by Palette Life Sciences — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anal tissue reconstructive material.
- Solesta® — SALIX PHARMACEUTICALS, LTD. · Class III
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 |
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Manufacturer
- Manufacturer
- Palette Life Sciences
Sources (1)
- FDA UDI d081f69f-7d48-4cdd-89b9-2b87df70d8c8 38 fields · synced Jun 1, 2026