Identity
- Trade Name
- GORE EXCLUDER AAA Endoprosthesis FDA UDI
- Generic Name
- Aortoiliac endovascular stent-graft FDA UDI
- Device Name
- Iliac Extender FDA UDI
- Model / Reference
- PXL161407 FDA UDI
- Description
- Iliac Extender FDA UDI
Identifiers
- Catalog Number
- PXL161407 FDA UDI
- Primary DI / UDI-DI
- 00733132610082 FDA UDI
- PMA Number
- P020004 FDA UDI
- FDA Product Code
- MIH FDA UDI
- GMDN Term
- Aortoiliac endovascular stent-graft FDA UDI
Classification
- Device Class
- Class III 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 Conditional FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 16 Millimeter FDA UDILumen/Inner Diameter — 14.5 Millimeter FDA UDILength — 7 Centimeter FDA UDI
Category: Aortoiliac endovascular stent-graft
GORE EXCLUDER AAA Endoprosthesis by W. L. Gore & Associates, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortoiliac endovascular stent-graft.
- Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
- TREO Abdominal Stent-Graft System — Bolton Medical Inc. · Class III
- Endurant® II — MEDTRONIC, INC. · Class III
- Zenith Spiral-Z — COOK INCORPORATED · Class III
- Zenith Renu — COOK INCORPORATED · Class III
- Endurant® II — MEDTRONIC, INC. · Class III
- Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
- Zenith Renu — COOK INCORPORATED · Class III
Cleared under the same submission
P020004 also covers:
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — W. L. GORE & ASSOCIATES, INC
- GORE EXCLUDER AAA Endoprosthesis — 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 III | Pending data |
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Manufacturer
- Manufacturer
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 03323628-00a2-445c-8ce7-7527105f73b9 37 fields · synced Jun 8, 2026