← Back to catalogue

Zilver PTX

FDA UDI

Class III (US FDA UDI)

by Cook Ireland, Ltd.

Identity

Trade Name
Zilver PTX FDA UDI
Generic Name
Drug-eluting peripheral artery stent, bare-metal FDA UDI
Device Name
Zilver PTX, Drug-Eluting Peripheral Stent FDA UDI
Model / Reference
G38416 FDA UDI
Description
Zilver PTX, Drug-Eluting Peripheral Stent FDA UDI

Identifiers

Catalog Number
ZISV6-35-125-5-140-PTX FDA UDI
Primary DI / UDI-DI
10827002384160 FDA UDI
FDA Product Code
NIU FDA UDI
GMDN Term
Drug-eluting 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

Yes

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: Drug-eluting peripheral artery stent, bare-metal

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

Similar devices

Also classified as Drug-eluting peripheral artery stent, bare-metal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cook Ireland, Ltd.

Sources (1)

  • FDA UDI 3965121a-949e-4396-8e32-ecc31b047a42 36 fields · synced Jun 8, 2026