Sternum saw blade, single-use

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

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Available from:
ConMed Linvatec Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
339339

Public Summary

Summary for ARTG Entry:

339339

ConMed Linvatec Australia Pty Ltd - Sternum saw blade, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

ConMed Linvatec Australia Pty Ltd

Postal Address

PO Box 6064, FRENCHS FOREST DC, NSW, 2086

Australia

ARTG Start Date

10/07/2020

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

Gebr Brasseler GmbH & Co KG

Trophagener Weg 25

, Lemgo Deutschland, 32657

Germany

Products

1 . Sternum saw blade, single-use

Product Type

Single Device Product

Effective Date

10/07/2020

GMDN

44632 Sternum saw blade, single-use

Intended Purpose

A sterile, single-use, flat metal surgical cutting instrument with a serrated edge, designed for attachment to a dedicated powered

handpiece used for cutting the sternum (breastbone) during cardiovascular surgery. It is available in various configurations (e.g.,

with cutting teeth arranged in a straight line or arc along the cutting edge) and cuts when the blade is powered in a rapid

reciprocating movement (a back and forth motion like a jigsaw).

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 22.07.2020 at 09:44:20 AEST

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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