Home GUDID 04953170356001 Balloon Applicator
Primary DI 04953170356001
Brand Balloon Applicator
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model MAJ-675
Device description """MAJ-675 Balloon applicator for GF-UC30P"""
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 ITX Transducer, ultrasonic, diagnostic IYN System, imaging, pulsed doppler, ultrasonic IYO System, imaging, pulsed echo, ultrasonic NWB Endoscope, accessories, narrow band spectrum ODG Endoscopic ultrasound system, gastroenterology-urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2 NWB Endoscope, Accessories, Narrow Band Spectrum 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 04953170356001 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04953170356001 04953170356001 4953170356001
GMDN Terms# Term, Definition table Term Definition Ultrasound endoscope balloon, Hevea-latex A sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use 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 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 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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