Retractor

Main information

  • Trade name:
  • Retractor system, self-retaining
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Retractor system, self-retaining
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219937
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219937

Matrix Medical Innovations Pty Ltd - Retractor system, self-retaining

ARTG entry for

Medical Device Included Class IIa

Sponsor

Matrix Medical Innovations Pty Ltd

Postal Address

Unit 10 / 9-11 Myrtle Street,CROWS NEST DC, NSW, 2065

Australia

ARTG Start Date

7/02/2014

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

Ulrich GmbH & Co KG

Buchbrunnenweg 12

, Ulm, 89081

Germany

Products

1. Retractor system, self-retaining

Product Type

Medical device system

Effective date

7/02/2014

GMDN

45181 Retractor system, self-retaining

Intended purpose

A frame retractor system to temporarily part tissue for anterior and lateral spinal access during surgery.

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 10.11.2017 at 05:58:40 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