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Oesophageal bougie, single-use - ARTG 470149

Access comprehensive regulatory information for Oesophageal bougie, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 470149 and sponsored by Teleflex Medical Australia Pty Ltd, manufactured by Teleflex Medical in United States of America. The device registration started on November 25, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class IIa
ARTG 470149
Class IIa
Oesophageal bougie, single-use
ARTG ID: 470149
Good Name: Teleflex Medical Australia Pty Ltd - Oesophageal bougie, single-use
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Intended Purpose

The bougie is indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide. This is a non-sterile device for single patient use. It can be connected to operating room suction, Standard Bougie Hand Pump or syringe.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
470149
Start Date
November 25, 2024
Effective Date
November 25, 2024
Manufacturer
Country
United States of America
Address
3015 Carrington Mill Boulevard, Morrisville, NC, 27560