Surgical procedure kit, orthopaedic,

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

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Available from:
Life Healthcare Pty Ltd
Class 1
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Life Healthcare Pty Ltd - Surgical procedure kit, orthopaedic, <specify>

ARTG entry for

Medical Device Included Class 1


Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Tecomet Inc

5307 95th Avenue

Kenosha, Wisconsin, 53144

United States Of America


1. Surgical procedure kit, orthopaedic, <specify>

Product Type

Single Device Product

Effective date



44055 Surgical procedure kit, orthopaedic, <specify>

Intended purpose

A collection of reusable surgical instruments used to perform an orthopaedic surgical procedure. This

device can be presented as a kit, tray or set. It is reusable after the appropriate cleaning/sterilizing of the

instruments/reusable products.

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

Public Summary

Page 1 of

Produced at 03.11.2017 at 04:55:44 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.

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