Woven

Main information

  • Trade name:
  • Woven gauze pad, sterile
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Woven gauze pad, sterile
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222057
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222057

Life Healthcare Pty Ltd - Woven gauze pad, sterile

ARTG entry for

Medical Device Included Class Is

Sponsor

Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

7/04/2014

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

Vostra GmbH

Im Susterfeld 3

Aachen, , D-52072

Germany

Products

1. Woven gauze pad, sterile

Product Type

Single Device Product

Effective date

7/04/2014

GMDN

48134 Woven gauze pad, sterile

Intended purpose

Adenotomy Swabs manufactured from gauze material are equipped with a sewn-in double thread. They

are designed for intra-operative wound treatment in the ENT field. It is sterile and available with or without

x-ray markings. They are indicated for the following procedures: adenotomy, tonsillectomy.

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 09.11.2017 at 10:55:39 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