Endoscopic bite block, oxygenating

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Trawax Pty Limited
Class:
Class 1
Authorization status:
Included
Authorization number:
321383

Public Summary

Summary for ARTG Entry:

321383

Trawax Pty Limited - Endoscopic bite block, oxygenating

ARTG entry for

Medical Device Included Class 1

Sponsor

Trawax Pty Limited

Postal Address

PO Box 237,Freshwater, NSW, 2096

Australia

ARTG Start Date

7/08/2019

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Trawax Pty Limited

28 Queenscliff Road

QUEENSCLIFF, NSW, 2096

Australia

Products

1. Endoscopic bite block, oxygenating

Product Type

Single Device Product

Effective date

7/08/2019

GMDN

47162 Endoscopic bite block, oxygenating

Intended purpose

An adult mouth guard to be used during gastroscopy to facilitate the entry of an endoscope. The device

allows connection of oxygen or gas line tubing with a port provided.

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 07:46:17 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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