Ring

FDA UDI

Class U (US FDA UDI)

by Cook Incorporated

Identity

Trade Name: Ring FDA UDI
Generic Name: Biliary drain FDA UDI
Device Name: Ring Biliary Duct Drainage Catheter Ultrathane FDA UDI
Model / Reference: G12643 FDA UDI
Description: Ring Biliary Duct Drainage Catheter Ultrathane FDA UDI

Identifiers

Catalog Number: ULT8.5-38-50-P-RING-25.5-MEH-RH FDA UDI
Primary DI / UDI-DI: 00827002126435 FDA UDI
FDA Product Code: LJE FDA UDI
GMDN Term: Biliary drain FDA UDI

Classification

Device Class: U 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: Biliary drain

Ring by Cook Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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LMI BILUMEN BILIARY CATHETER DISTAL — LUCAS MEDICAL INC · Class II
Redondrain PU Ch.12 Länge 800 mm / Perforation 150 mm, graduiert, röntgenfähig steril, gewickelt, DEHP frei — Primed Halberstadt Medizintechnik GmbH · Class IIa
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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 U	Pending data

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Manufacturer

Manufacturer: Cook Incorporated

Sources (1)

FDA UDI b296c149-b8ff-40c6-a9dc-beb4c4d50550 36 fields · synced Jun 7, 2026