Identity
- Trade Name
- Zenith Alpha FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- Zenith Alpha, Thoracic Endovascular Graft, Distal Component FDA UDI
- Model / Reference
- G35395 FDA UDI
- Description
- Zenith Alpha, Thoracic Endovascular Graft, Distal Component FDA UDI
Identifiers
- Catalog Number
- ZTA-D-38-147-W FDA UDI
- Primary DI / UDI-DI
- 10827002353951 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Synthetic vascular graft
Zenith Alpha by William Cook Europe ApS — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- William Cook Europe ApS
Sources (1)
- FDA UDI b3b78164-bdb0-4160-be9a-93b1634a4ac2 37 fields · synced May 30, 2026