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Cotton-Leung

FDA UDI

Class II (US FDA UDI)

by Cook Ireland, Ltd.

Identity

Trade Name
Cotton-Leung FDA UDI
Generic Name
Polymeric biliary stent, non-bioabsorbable FDA UDI
Device Name
Cotton-Leung Biliary Stent FDA UDI
Model / Reference
G27148 FDA UDI
Description
Cotton-Leung Biliary Stent FDA UDI

Identifiers

Catalog Number
CLSO-8.5-6 FDA UDI
Primary DI / UDI-DI
00827002271487 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Polymeric biliary stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 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: Polymeric biliary stent, non-bioabsorbable

Cotton-Leung by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric biliary stent, non-bioabsorbable.

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 cf954258-6277-4faa-a174-e8ebc290f7f0 36 fields · synced Jun 8, 2026