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Zilver 635

FDA UDI

Class III (US FDA UDI)

by Cook Ireland, Ltd.

Identity

Trade Name
Zilver 635 FDA UDI
Generic Name
Peripheral artery stent, bare-metal FDA UDI
Device Name
Zilver 635 Vascular Stent FDA UDI
Model / Reference
G43865 FDA UDI
Description
Zilver 635 Vascular Stent FDA UDI

Identifiers

Catalog Number
ZIV6-35-80-10-30 FDA UDI
Primary DI / UDI-DI
10827002438658 FDA UDI
FDA Product Code
NIO FDA UDI
GMDN Term
Peripheral artery stent, bare-metal 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
MRI Safety
MR Conditional FDA UDI

Category: Peripheral artery stent, bare-metal

Zilver 635 by Cook Ireland, Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral artery stent, bare-metal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Ireland, Ltd.

Sources (1)

  • FDA UDI f87ed4aa-119a-4103-ba6a-22ccb2cb767d 36 fields · synced Jun 6, 2026