Latex-free Biliary Catherter

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: Latex-free Biliary Catherter FDA UDI
Generic Name: Biliary drain FDA UDI
Device Name: Removal of stones and ductal debris from the biliary system. FDA UDI
Model / Reference: CB054008 FDA UDI
Description: Removal of stones and ductal debris from the biliary system. FDA UDI

Identifiers

Primary DI / UDI-DI: 00607915117351 FDA UDI
FDA Product Code: FGE FDA UDI
GMDN Term: Biliary drain 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

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

FDA UDI

Dimensions & Sizes

Size: Length — 40 Centimeter FDA UDI
Catheter Gauge — 5 French FDA UDI

Category: Biliary drain

Latex-free Biliary Catherter by Applied Medical Resources Corp. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI 5740e902-b6f7-486d-bfed-c24509562920 35 fields · synced Jun 8, 2026