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Oesophageal bougie, single-use

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 I is sponsored by LSR Healthcare Pty Ltd, manufactured by Adroit Surgical LLC in United States of America. The device registration started on October 18, 2019.

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 I
Class I
Oesophageal bougie, single-use
Australia TGA ARTG Registered Device
Good Name: LSR Healthcare Pty Ltd- Oesophageal bougie, single-use
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Intended Purpose

Designed to help guide the direction of the endotracheal tube (ETT) between the vocal cords. The Bougie has clearly marked colored bands that allow the user to quickly insert the Bougie the correct distance.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 18, 2019
Effective Date
October 18, 2019
Manufacturer
Country
United States of America
Address
13904 Quailbrook Drive, Oklahoma City, OK, 73134