Home GUDID 04953170061837 ULTRASONIC PROBE
Primary DI 04953170061837
Brand ULTRASONIC PROBE
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model RU-75M-R1
Device description """5786230 OLA RU-75M-R1 RIGID ULTRASOUND R"""
Published 2017-10-06
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FDF Colonoscope and accessories, flexible/rigid FDS Gastroscope and accessories, flexible/rigid FDT Duodenoscope and accessories, flexible/rigid ODG Endoscopic ultrasound system, gastroenterology-urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04953170061837 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04953170061837 04953170061837 4953170061837
GMDN Terms# Term, Definition table Term Definition Rectal/vaginal ultrasound imaging transducer An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.
Sterilization Methods# Method table Method "[""High-level Disinfectant"", ""Ethylene Oxide""]" High-level Disinfectant;Ethylene Oxide
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 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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