Sterilization packaging, single-use

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

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Available from:
ACRA Regulatory Services Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
323764

Public Summary

Summary for ARTG Entry:

323764

ACRA Regulatory Services Pty Ltd - Sterilization packaging, single-use

ARTG entry for

Medical Device Included Class 1

Sponsor

ACRA Regulatory Services Pty Ltd

Postal Address

7/84 Poincina Avenue,Tewantin, QLD, 4565

Australia

ARTG Start Date

18/09/2019

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

Rups Packaging Industry

A-196 Sector 83

, Noida, 201 305

India

Products

1. Sterilization packaging, single-use

Product Type

Single Device Product

Effective date

18/09/2019

GMDN

13735 Sterilization packaging, single-use

Intended purpose

Sterilization medical grade pouches and paper rolls intended to be used to enclose another medical device

in a single pouch configuration 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

Specific Conditions

© 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 08.11.2019 at 10:20:37 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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