Catheter, gastrointestinal balloon
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
10-11-2017
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Available from:
Fujifilm Australia Pty Ltd
Class:
Class IIa
Manufactured by:
Fujifilm Corporation 26-30 Nishiazabu 2 Chome, MINATO KU TOKYO, 106 8620 Japan
Therapeutic area:
45712 - Catheter, gastrointestinal balloon
Therapeutic indications:
This product is a balloon for containing the ultrasonic transmitting medium to be used in combination with an ultrasonic endoscope in a medical facility under the supervision of a physician. This product is not intended to be used for children or infants.
Authorization status:
A
Authorization date:
2013-10-25
