Home GUDID 04953170058882 BALLOON3
Primary DI 04953170058882
Brand BALLOON3
Company OLYMPUS MEDICAL SYSTEMS CORP.
Model MAJ-249
Published 2017-10-12
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name ODG Endoscopic ultrasound system, gastroenterology-urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14953170058889 Package GS1 20 Not in Commercial Distribution 04953170058882 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14953170058889 14953170058889 04953170058882 04953170058882 4953170058882
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.
Regulatory Flags# DUNS number 711789789 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use false 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 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 04953170235665 SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm T3905 2017-10-06
Other Devices Sharing Product Codes# 
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