Stomal depth sizer

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

Buy It Now

Available from:
Device Technologies Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
321476

Public Summary

Summary for ARTG Entry:

321476

Device Technologies Australia Pty Ltd - Stomal depth sizer

ARTG entry for

Medical Device Included Class IIa

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

8/08/2019

Product category

Medical Device Class IIa

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

Applied Medical Technology Inc

8006 Katherine Boulevard

Brecksville, OH, 44141

United States Of America

Products

1. Stomal depth sizer

Product Type

Single Device Product

Effective date

8/08/2019

GMDN

63942 Stomal depth sizer

Intended purpose

An enteral feeding accessory used to assist in the selection of the appropriate feeding tube by measuring

the length of stoma tract.

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 07:34:58 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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