Dressing

Main information

  • Trade name:
  • Dressing, wound-nonadherent, absorbent
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Dressing, wound-nonadherent, absorbent
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216314
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216314

Livingstone International Pty Ltd - Dressing, wound-nonadherent, absorbent

ARTG entry for

Medical Device Included Class Is

Sponsor

Livingstone International Pty Ltd

Postal Address

106-116 Epsom Road,ROSEBERY, NSW, 2018

Australia

ARTG Start Date

22/10/2013

Product category

Medical Device Class Is

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

Danyang Sunmed Healthcare Co

No 3 Bei Er Huan Danyang City

, Jiangsu Province, 212300

China

Products

1. Dressing, wound-nonadherent, absorbent

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

46854 Dressing, wound-nonadherent, absorbent

Intended purpose

"A sterile wound covering typically in the form of a pad (usually with additional layers) having a material or

substance on its skin-contact surface (e.g., silicone gel) that prevents adherence to the wound bed,

thereby decreasing the potential for trauma to the wound and/or causing pain upon removal. It is typically

used to absorb blood and exudates from the wound, while protecting the wound from external

contamination and maintaining a moist internal environment. This device may be used as a primary or

secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns,

ulcers, abrasions, cuts, or puncture sites. 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 05:21:59 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