Zenith Alpha

FDA UDI

Class III (US FDA UDI)

by William Cook Europe ApS

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: G35403 FDA UDI
Description: Zenith Alpha, Thoracic Endovascular Graft, Distal Component FDA UDI

Identifiers

Catalog Number: ZTA-D-46-157-W FDA UDI
Primary DI / UDI-DI: 10827002354033 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

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

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: William Cook Europe ApS

Sources (1)

FDA UDI 0bb60d56-099e-4479-9164-29ac0af0de68 37 fields · synced May 31, 2026