a1f8620a-b167-4531-a811-9b606ef19556UpdatePublished42023-01-162016-09-21In Commercial Distribution04953170360428PrimaryGS184953170360424Unit of UseGS1BALLOON3MAJ-233711789789OLYMPUS MEDICAL SYSTEMS CORP.20falsefalsefalsefalsefalsetruetruefalsefalsetruefalsetruefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)401-1086xx@xx.xx61506Ultrasound endoscope balloon, Hevea-latexA 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.falseActiveFDFColonoscope and accessories, flexible/rigidITXTransducer, ultrasonic, diagnostictruefalse