← Back to catalogue

Biliary Drainage Tube

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
Biliary Drainage Tube FDA UDI
Generic Name
Polymeric biliary stent, non-bioabsorbable FDA UDI
Device Name
Biliary Drainage Tube FDA UDI
Model / Reference
PBD-421-1011 FDA UDI
Description
Biliary Drainage Tube FDA UDI

Identifiers

Primary DI / UDI-DI
04953170046988 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

No

FDA UDI

Category: Polymeric biliary stent, non-bioabsorbable

Biliary Drainage Tube by Olympus Medical Systems Corporation — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 4f6c99dd-a4df-4efe-a2a3-a7f53a20591b 34 fields · synced Jun 8, 2026