Identity
- Trade Name
- X-RepairSL FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 20mm (WxL) FDA UDI
- Model / Reference
- Z020-20SL FDA UDI
- Description
- X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 20mm (WxL) FDA UDI
Identifiers
- Catalog Number
- Z020-20SL FDA UDI
- Primary DI / UDI-DI
- B05502020 FDA UDI
- 510(k) Number
- K141499 FDA UDI
- FDA Product Code
- FTL FDA UDIOWW 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 4 Millimeter FDA UDILength — 20 Millimeter FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
X-RepairSL by Synthasome, 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
- Synthasome, Inc.
Sources (1)
- FDA UDI e9507101-0c97-43f1-8f3f-6cb5bd5c95b0 37 fields · synced Jun 1, 2026