Identity
- Trade Name
- Zenith Alpha FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- Zenith Alpha 2, Thoracic Endovascular Graft Proximal Component FDA UDI
- Model / Reference
- G59996 FDA UDI
- Description
- Zenith Alpha 2, Thoracic Endovascular Graft Proximal Component FDA UDI
Identifiers
- Catalog Number
- ZTA2-P-32-155-W FDA UDI
- Primary DI / UDI-DI
- 00827002599963 FDA UDI
- PMA Number
- P140016 FDA UDI
- FDA Product Code
- MIH FDA UDI
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Synthetic vascular graft
The Zenith Alpha is a revolutionary synthetic vascular graft designed to replace or bypass diseased or injured blood vessels, typically in the aorta, iliac, femoral, or popliteal arteries. Made from woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics, it is not intended for use in coronary arteries and does not incorporate a metallic mesh.
Similar devices
Also classified as Synthetic vascular graft.
- Gelweave™ — VASCUTEK LTD · Class II
- GORE PROPATEN Vascular Graft Pediatric Shunt — W. L. GORE & ASSOCIATES, INC · Class II
- Gelweave™ — VASCUTEK LTD · Class II
- Gelweave™ — VASCUTEK LTD · Class II
- Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
- ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
- Gelweave Vascular Prostheses — VASCUTEK LTD · Class II
- IMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular · Class II
Cleared under the same submission
P140016 also covers:
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
- Zenith Alpha — William Cook Europe ApS
Authorization Coverage (1 country)
Regulatory Authorizations
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
- William Cook Europe ApS
Sources (1)
- FDA UDI a54e9507-f4ee-4b45-8fb9-ea9d4bc60a9c 37 fields · synced Jul 22, 2026