Identity
- Trade Name
- DuraSorb Monofilament Mesh FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- Monfilament Mesh FDA UDI
- Model / Reference
- PTM1025 FDA UDI
- Description
- Monfilament Mesh FDA UDI
Identifiers
- Catalog Number
- PTM1025 FDA UDI
- Primary DI / UDI-DI
- 00860000875905 FDA UDI
- 510(k) Number
- K181094 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
DuraSorb Monofilament Mesh by Surgical Innovation Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable.
- PDS Plates — Ethicon Inc. · Class II
- Vivosorb — Polyganics Innovations B.V. · Class II
- Ballast — ISOTIS ORTHOBIOLOGICS, INC · Class II
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC · Class II
- GalaFLEX 3D — Tepha, Inc. · Class II
- TIGR® Matrix Surgical Mesh — Novus Scientific AB · Class II
- Phasix — Davol Inc. · Class II
- GalaFLEX LITE — Tepha, Inc. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgical Innovation Associates, Inc.
Sources (1)
- FDA UDI b1578134-0431-4fe4-a40d-ef21ce311ca8 37 fields · synced May 30, 2026