Identity
- Trade Name
- GORE-TEX Soft Tissue Patch FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- GORE-TEX SOFT TISSUE PATCH 10.0cmX15.0cmX1.0mm FDA UDI
- Model / Reference
- 1410015010 FDA UDI
- Description
- GORE-TEX SOFT TISSUE PATCH 10.0cmX15.0cmX1.0mm FDA UDI
Identifiers
- Catalog Number
- 1410015010 FDA UDI
- Primary DI / UDI-DI
- 00733132600595 FDA UDI
- 510(k) Number
- K963619 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, non-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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Centimeter FDA UDILength — 15 Centimeter FDA UDIHeight — 1 Millimeter FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
GORE-TEX Soft Tissue Patch 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, non-bioabsorbable.
- COMPOSIX — Davol Inc. · Class II
- SurgiMesh — BG MEDICAL, LLC · Class II
- HERMESH — Herniamesh · Class II
- Hermesh — Herniamesh · Class II
- HERMESH — Herniamesh · Class II
- BARD — Davol Inc. · Class II
- Bard — Davol Inc. · Class II
- 3DMAX — Davol Inc. · Class II
Cleared under the same submission
K963619 also covers:
- GORE-TEX Soft Tissue Patch — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Soft Tissue Patch — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Soft Tissue Patch — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Soft Tissue Patch — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Soft Tissue Patch — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Soft Tissue Patch — 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 998b3b16-450e-434d-9679-a82182d6d076 37 fields · synced May 30, 2026