Identity
- Trade Name
- GORE PRECLUDE Dura Substitute FDA UDI
- Generic Name
- Dura mater graft, synthetic FDA UDI
- Device Name
- GORE PRECLUDE DURA SUBSTITUTE 15.0cmX20.0cmX0.1mm FDA UDI
- Model / Reference
- 1PDS152 FDA UDI
- Description
- GORE PRECLUDE DURA SUBSTITUTE 15.0cmX20.0cmX0.1mm FDA UDI
Identifiers
- Catalog Number
- 1PDS152 FDA UDI
- Primary DI / UDI-DI
- 00733132601936 FDA UDI
- 510(k) Number
- K953969 FDA UDI
- FDA Product Code
- GXQ FDA UDI
- GMDN Term
- Dura mater graft, synthetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5910 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
Dimensions & Sizes
- Size
- Width — 15 Centimeter FDA UDILength — 20 Centimeter FDA UDI
Category: Dura mater graft, synthetic
GORE PRECLUDE Dura Substitute by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dura mater graft, synthetic.
- ArtiFascia® — Nurami Medical , Ltd. · Class II
- ArtiFascia® — Nurami Medical , Ltd. · Class II
- NEURO-PATCH — AESCULAP, INC. · Class II
- Cerafix® Dura Substitute — Acera Surgical Inc · Class II
- Cerafix® Dura Substitute — Acera Surgical Inc · Class II
- NEURO-PATCH — AESCULAP, INC. · Class II
- ArtiFascia® — Nurami Medical , Ltd. · Class II
- NEURO-PATCH — AESCULAP, INC. · Class II
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
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 9a6d90f2-4668-4743-9288-437159858660 37 fields · synced Jun 8, 2026