Home GUDID 14953170372299 Single Use Biliary Balloon Dilator
Primary DI 14953170372299
Brand Single Use Biliary Balloon Dilator
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model BD-210N-0620
Device description Single Use Biliary Balloon Dilator
Published 2017-09-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 14953170372299 Package GS1 1 In Commercial Distribution 04953170372292 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14953170372299 14953170372299 04953170372292 04953170372292 4953170372292
GMDN Terms# Term, Definition table Term Definition Biliary stone retrieval balloon catheter A flexible, tubular, manual endotherapy device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) in the biliary tract. It is inserted through the working channel of an endoscope, typically beyond the stones where the balloon is inflated and retracted, the balloon pushing the trapped stones before it out of the biliary tract. 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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04953170047671 VALVULOTOME (DETACHABLE TYPE) C-0103B 2016-09-21 04953170047695 VALVULOTOME (DETACHABLE TYPE) C-0104B 2016-09-21 04953170468308 Single Use BML Handle V MAJ-2502 N6154531 2026-10-19 04953170428142 VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR N5427045 2021-03-03 04953170386138 VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR 2021-02-07 04953170379611 HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB 2019-09-12 04953170386022 VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200 2019-09-12 04953170393204 HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA 2019-09-12 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
Other Devices Sharing Product Codes# 
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