Wound

Main information

  • Trade name:
  • Wound hydrogel dressing, sterile
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Wound hydrogel dressing, sterile
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221543
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221543

Aero Healthcare - Wound hydrogel dressing, sterile

ARTG entry for

Medical Device Included Class IIa

Sponsor

Aero Healthcare

Postal Address

PO Box 1635,ARMIDALE, NSW, 2350

Australia

ARTG Start Date

21/03/2014

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

Aero Health Aust Pty Ltd T/A Australia Aero

Healthcare

63 Seaton Street

ARMIDALE, NSW, 2350

Australia

Products

1. Wound hydrogel dressing, sterile

Product Type

Single Device Product

Effective date

21/03/2014

GMDN

47764 Wound hydrogel dressing, sterile

Intended purpose

A sterile wound covering impregnated with gel for first aid treatment of minor burns. The device is intended

to cool the burn and soothe pain. It also acts a mechanical barrier to help protect the wound from infection.

It may also absorb exudates in wounds that are minimally to moderately exudative. This is a single-use

device.

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 10.11.2017 at 12:43:02 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

There are no safety alerts related to this product.

2-10-2018

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