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Single Use 3-Lumen Extraction Balloon V

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
Single Use 3-Lumen Extraction Balloon V FDA UDI
Generic Name
ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
Device Name
Single Use 3-Lumen Extraction Balloon V FDA UDI
Model / Reference
B-V233P-A FDA UDI
Description
Single Use 3-Lumen Extraction Balloon V FDA UDI

Identifiers

Primary DI / UDI-DI
04953170275692 FDA UDI
FDA Product Code
LQR FDA UDI
FGE FDA UDI
GMDN Term
ERCP catheter, balloon, non-electrical, stone-retrieval 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

No

FDA UDI

Contains Latex

Yes

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: ERCP catheter, balloon, non-electrical, stone-retrieval

Single Use 3-Lumen Extraction Balloon V by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ERCP catheter, balloon, non-electrical, stone-retrieval.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI bb17dee9-c880-403d-8807-0e8d8fdc9529 34 fields · synced May 29, 2026