Identity
- Trade Name
- GORE Embolic Filter FDA UDI
- Generic Name
- Embolic protection filtering guidewire FDA UDI
- Device Name
- 5MM FILTER ON 300CM GUIDEWIRE FDA UDI
- Model / Reference
- GEFA015300 FDA UDI
- Description
- 5MM FILTER ON 300CM GUIDEWIRE FDA UDI
Identifiers
- Catalog Number
- GEFA015300 FDA UDI
- Primary DI / UDI-DI
- 00733132618262 FDA UDI
- FDA Product Code
- NTE FDA UDI
- GMDN Term
- Embolic protection filtering guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
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
- Outer Diameter — 5 Millimeter FDA UDILength — 300 Centimeter FDA UDI
GORE Embolic Filter 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 7b6b4180-ab31-4ece-ad77-28ee4c6709c7 37 fields · synced Jun 6, 2026