Cap, surgical, single use

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

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Available from:
Healthscope Operations PTY LTD
Class:
Class 1
Authorization status:
Included
Authorization number:
321862

Public Summary

Summary for ARTG Entry:

321862

Healthscope Operations PTY LTD - Cap, surgical, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Healthscope Operations PTY LTD

Postal Address

PO Box 7586,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

16/08/2019

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

Hubei Haixin Protective Products Co Ltd

Jinsong Avenue No 8-8 Chendong Industrial

Zone

Songzi City, Hubei Province, 434200

China

Products

1. Cap, surgical, single use

Product Type

Single Device Product

Effective date

16/08/2019

GMDN

32297 Cap, surgical, single use

Intended purpose

Intended to be worn by surgical staff during an operation to protect both the patient and the operating

room personnel from transfer of micro-organisms, body fluids and particulate material.

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 02.11.2019 at 06:42:09 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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