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GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- BSGEC45 Anvil & Cartridge FDA UDI
- Model / Reference
- BSGEC45AC FDA UDI
- Description
- BSGEC45 Anvil & Cartridge FDA UDI
Identifiers
- Catalog Number
- BSGEC45AC FDA UDI
- Primary DI / UDI-DI
- 00733132626991 FDA UDI
- 510(k) Number
- K043056 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce by W. L. Gore & 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
- 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
- NEOVEIL — GUNZE LIMITED · Class II
Cleared under the same submission
K043056 also covers:
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC
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
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI e0243777-d349-43e9-b3a0-cf421a3273e8 36 fields · synced Jun 6, 2026