Bag, colostomy, closed-ended, one-piece

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

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Available from:
Omnigon Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
293184

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Public Summary

Summary for ARTG Entry:

293184

Omnigon Pty Ltd - Bag, colostomy, closed-ended, one-piece

ARTG entry for

Medical Device Included Class 1

Sponsor

Omnigon Pty Ltd

Postal Address

PO Box 5013,Burnley, VIC, 3132

Australia

ARTG Start Date

25/08/2017

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

Welland Medical Ltd

7/8 Brunei Centre Newton Road

Crawley, West Sussex, RH10 2TU

United Kingdom

Products

1. Bag, colostomy, closed-ended, one-piece

Product Type

Single Device Product

Effective date

25/08/2017

GMDN

31066 Bag, colostomy, closed-ended, one-piece

Intended purpose

Aurum Profile Colostomy is intended to collect human faecal waste by attachment to the skin around a

stoma using an adhesive flange incorporating Manuka Honey. The flexible, mouldable flange is intended

for users with uneven skin around the stoma, such as a hernia.

Specific Conditions

No Specific Conditions included on Record

© 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 03.11.2017 at 05:30:25 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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