Identity
- Trade Name
- Solesta® FDA UDI
- Generic Name
- Anal tissue reconstructive material FDA UDI
- Device Name
- SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications). FDA UDI
- Model / Reference
- 1085003 FDA UDI
- Description
- SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00365649850035 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
Category: Anal tissue reconstructive material
Solesta® by Salix Pharmaceuticals, Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anal tissue reconstructive material.
- Solesta — PALETTE LIFE SCIENCES · 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
- Salix Pharmaceuticals, Ltd.
Sources (1)
- FDA UDI deb3c664-29a9-4a16-8813-38ea2ffe3bbb 34 fields · synced May 30, 2026