Device Dossier
Catheter, gastrointestinal balloon
Device Dossier for Catheter, gastrointestinal balloon (Catheter, gastrointestinal balloon, Class IIa, sponsor Fujifilm). ARTG record, intended purpose,…
- GMDN category: Catheter, gastrointestinal balloon
Intended purpose
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.