Surgical procedure kit, general-purpose, single-use, non-medicated

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

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Available from:
O&M Halyard Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322923

Public Summary

Summary for ARTG Entry:

322923

O&M Halyard Australia Pty Ltd - Surgical procedure kit, general-purpose, single-use, non-medicated

ARTG entry for

Medical Device Included Class IIa

Sponsor

O&M Halyard Australia Pty Ltd

Postal Address

52 Alfred Street,Milsons Point, NSW, 2061

Australia

ARTG Start Date

9/09/2019

Product category

Medical Device Class IIa

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

GRI Medical & Electronic Technology Co Ltd

1805 Honggao Road

Jiaxing, Zhejiang, 314031

China

Products

1. Surgical procedure kit, general-purpose, single-use, non-medicated

Product Type

Procedure Pack

Effective date

9/09/2019

GMDN

33961 Surgical procedure kit, general-purpose, single-use, non-medicated

Intended purpose

Procedure Pack containing medical device components and other items to be used for general surgical

procedures.

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 04:41:30 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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