Cook

FDA UDI

Class U (US FDA UDI)

by Cook Incorporated

Identity

Trade Name: Cook FDA UDI
Generic Name: Biliary drain FDA UDI
Device Name: Drainage Catheter Needle Set FDA UDI
Model / Reference: G56889 FDA UDI
Description: Drainage Catheter Needle Set FDA UDI

Identifiers

Catalog Number: DUAN-5.0-19.5-25.0-6S-PIG FDA UDI
Primary DI / UDI-DI: 00827002568891 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 Safe FDA UDI

Category: Biliary drain

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

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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 a00a40c4-090f-4c4a-b100-aa9534c547b4 36 fields · synced Jun 8, 2026