Home GUDID 04953170183430 Single Use 3-Lumen Extraction Balloon V
Primary DI 04953170183430
Brand Single Use 3-Lumen Extraction Balloon V
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model B-V231P-A
Device description Single Use 3-Lumen Extraction Balloon V
Published 2016-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FGE CATHETER, BILIARY, DIAGNOSTIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14953170183437 Package GS1 1 Not in Commercial Distribution 04953170183430 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14953170183437 14953170183437 04953170183430 04953170183430 4953170183430
GMDN Terms# Term, Definition table Term Definition ERCP catheter, balloon, non-electrical, stone-retrieval A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.
Regulatory Flags# DUNS number 711789789 Device count 1 Lot or batch true Expiration date on label true Contains natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04953170474958 THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type S TB-0545FCS N5423341 2026-10-05 04953170474965 THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type S TB-0545FCS N5423441 2026-10-05 04953170474972 THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCS N5423641 2026-10-05 04953170474989 THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCS N5423741 2026-10-05 04953170474996 THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S TB-0520FCS N5423941 2026-10-05 04953170475009 THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S TB-0520FCS N5424041 2026-10-05 04953170025693 P CORD MAJ-3 4812500 2016-09-21 04953170048548 A CORD MH-969 2016-09-21 04953170062872 A CORD MAJ-860 2016-09-21 04953170373763 ENDOCAPSULE SOFTWARE 10 MAJ-2188 N5400340 2016-09-21 04953170373800 ENDOCAPSULE SOFTWARE 10 LIGHT MAJ-2189 N5400440 2016-09-21 04953170373848 ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE MAJ-2190 N5400540 2016-09-21 04953170360817 ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT MAJ-2038 N5368840 2023-06-21 04953170360824 ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENT MAJ-2039 N5368940 2023-06-21 04953170410178 EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 N6003140 2025-11-19 04953170411939 Single Use Biopsy Forceps FB-456D FB-456D N6008330 2020-09-29 04953170424724 Infrared imaging unit MAJ-2304 N5769545 2021-05-31 04953170428142 VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR N5427045 2021-03-03 04953170054358 Brush MH-362 4116800 2016-09-21 04953170058783 BALLOON3 MAJ-233 2017-10-12
Other Devices Sharing Product Codes# 
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