Device Dossier
Tube, gastric calibration
Device Dossier for Tube, gastric calibration (Tube, gastric calibration, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category —…
- GMDN category: Tube, gastric calibration
Intended purpose
The device is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures including gastrectomy, fundoplication, gastric banding, vertical banded gastroplasty, and gastric bypass. The device provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid, and size a gastric pouch.