Home GUDID 04953170355493 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Primary DI 04953170355493
Brand EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model OLYMPUS TGF-UC180J
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FBN Choledochoscope and accessories, flexible/rigid NWB Endoscope, accessories, narrow band spectrum
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04953170355493 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04953170355493 04953170355493 4953170355493
GMDN Terms# Term, Definition table Term Definition Flexible ultrasound gastroduodenoscope An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The probe may be built-in, or inserted through a dedicated lumen. This device is commonly used to examine structures of the stomach, duodenum, pancreas, and bile duct. This is a reusable device.
Sterilization Methods# Method table Method "[""Ethylene Oxide"", ""High-level Disinfectant""]" Ethylene Oxide;High-level Disinfectant
Regulatory Flags# DUNS number 711789789 Device count 1 DM exempt true Serial number true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 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
Other Devices Sharing Product Codes# 
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