Identity
- Trade Name
- GORE PRECLUDE PDX Dura Substitute FDA UDI
- Generic Name
- Dura mater graft, synthetic FDA UDI
- Model / Reference
- 1PDX301 FDA UDI
Identifiers
- Catalog Number
- 1PDX301 FDA UDI
- Primary DI / UDI-DI
- 00733132601950 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
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 5 Centimeter FDA UDILength — 6 Centimeter FDA UDI
GORE PRECLUDE PDX Dura Substitute by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 ee1a79db-6ffd-4428-b502-71a81f9fb255 36 fields · synced May 31, 2026