Home GUDID 04953170071416 DISTAL COVER
Primary DI 04953170071416
Brand DISTAL COVER
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model MAJ-411
Catalog number GV897000
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 FDT Duodenoscope And Accessories, Flexible/Rigid FET Endoscopic video imaging system/component, gastroenterology-urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04953170071416 Primary GS1 0 84953170071412 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04953170071416 04953170071416 4953170071416 84953170071412 84953170071412
GMDN Terms# Term, Definition table Term Definition Flexible video duodenoscope, reusable An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine structures and mucous membranes of the duodenum for conditions like ulcers, polyps, and cancer. This is a reusable device.
Sterilization Methods# Method table Method "[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant""]" Moist Heat or Steam Sterilization;High-level Disinfectant
Regulatory Flags# DUNS number 711789789 Device count 2 DM exempt true Lot or batch 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 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 04953170058882 BALLOON3 MAJ-249 2017-10-12 04953170142628 SonoSurg Transducer SonoSurg-T2H-C 2017-10-06 04953170208485 Cleaning brush MAJ-1534 N2301000 2016-09-21 04953170234859 SonoSurg Straight Scissors,Pistol Grip,5mm x 34cm T3771 2017-10-06 04953170234880 SonoSurg Curved Scissors,Pistol Grip,5mm x 34cm T3775 2017-10-06 04953170234941 SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cm T3900 2017-10-06 04953170235030 SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cm T3915 2017-10-06 04953170235122 SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cm T3930 2017-10-06 04953170235153 SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cm T3935 2017-10-06
Other Devices Sharing Product Codes# 
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