← Back to catalogue

Gianturco-Rosch Cook-Z

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Gianturco-Rosch Cook-Z FDA UDI
Generic Name
Bare-metal tracheal/bronchial stent FDA UDI
Device Name
Cook-Z Stent Gianturco-Rosch Tracheobronchial Design FDA UDI
Model / Reference
G08556 FDA UDI
Description
Cook-Z Stent Gianturco-Rosch Tracheobronchial Design FDA UDI

Identifiers

Catalog Number
GTZS-35-5.0 FDA UDI
Primary DI / UDI-DI
00827002085565 FDA UDI
FDA Product Code
JCT FDA UDI
GMDN Term
Bare-metal tracheal/bronchial stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3720 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

Category: Bare-metal tracheal/bronchial stent

Gianturco-Rosch Cook-Z by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal tracheal/bronchial stent.

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 Incorporated

Sources (1)

  • FDA UDI 4b7fed0d-150b-4a90-aca8-7719ccd05765 36 fields · synced Jun 8, 2026