Sterilization

Main information

  • Trade name:
  • Sterilization packaging,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sterilization packaging,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219902
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219902

Medline International Two Australia Pty Ltd - Sterilization packaging, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Medline International Two Australia Pty Ltd

Postal Address

PO Box 4366,MARAYONG, NSW, 2148

Australia

ARTG Start Date

5/02/2014

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

Medline Industries Inc

1200 Townline Road One Medline Place

Mundelein, IL, 60060

United States Of America

Products

1. Sterilization packaging, <specify>

Product Type

Single Device Product

Effective date

5/02/2014

GMDN

37395 Sterilization packaging, <specify>

Intended purpose

A device intended to enclose medical devices that are to be sterilized. It is designed to allow sterilization of

the enclosed medical device and also to maintain sterility of the device until the packaging is opened for

use of the device, or until a predetermined shelf date is expired.

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 06:08:38 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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