Suture/needle passer

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

Buy It Now

Available from:
Medtronic Australasia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
324072

Public Summary

Summary for ARTG Entry:

324072

Medtronic Australasia Pty Ltd - Suture/needle passer

ARTG entry for

Medical Device Included Class 1

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

26/09/2019

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

Ackermann Instrumente GmbH

Eisenbahnstrasse 65-67

Rietheim, Weilheim, D-78604

Germany

Products

1. Suture/needle passer

Product Type

Single Device Product

Effective date

26/09/2019

GMDN

37839 Suture/needle passer

Intended purpose

It is intended to feed and retrieve suture to close the port site wound, it is used with the VersaOne fascial

closure system trocars.

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 03:41:40 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