Surgical procedure kit, orthopaedic,

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

Buy It Now

Available from:
Life Healthcare Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
293392

Read the complete document

Public Summary

Summary for ARTG Entry:

293392

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

ARTG entry for

Medical Device Included Class 1

Sponsor

Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

30/08/2017

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

Tecomet Inc

5307 95th Avenue

Kenosha, Wisconsin, 53144

United States Of America

Products

1. Surgical procedure kit, orthopaedic, <specify>

Product Type

Single Device Product

Effective date

30/08/2017

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

Search alerts related to this product

Share this information