Home GUDID 04953170373954 Single Use Balloon Dilator V (with Knife)
Primary DI 04953170373954
Brand Single Use Balloon Dilator V (with Knife)
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model BD-VC431Q-1840-20
Published 2016-09-21
Public version status Update
Distribution status 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 KNS Unit, electrosurgical, endoscopic (with or without accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology 2 KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14953170373951 Package GS1 1 In Commercial Distribution 04953170373954 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14953170373951 14953170373951 04953170373954 04953170373954 4953170373954
GMDN Terms# Term, Definition table Term Definition ERCP catheter, balloon, electrosurgical, sphincter-dilation A flexible, multi-purpose, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy); and 3) balloon dilate the opening to the biliary tract, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire, an inflatable balloon and an inner lumen(s). It is intended to be used alongside separate devices designed for the removal of biliary stones. This is a single-use device.
Regulatory Flags# DUNS number 711789789 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true 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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