Retractor

Main information

  • Trade name:
  • Retractor,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Retractor,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220438
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220438

Health Care Surgical - Retractor, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Health Care Surgical

Postal Address

40 Hubert Street,FAIRFIELD, NSW, 2165

Australia

ARTG Start Date

25/02/2014

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

Rebstock Instruments GmbH

In Weiheracker 7

Durbheim, , D 78589

Germany

Products

1. Retractor, <specify>

Product Type

Medical device system

Effective date

25/02/2014

GMDN

13373 Retractor, <specify>

Intended purpose

An assembly of devices used to create a self-locking mechanism to temporarily part tissue(eg hold the

edges of a wound open), or other anatomical structures, to expose internal tissues or organs for access

during surgery. The component parts are typically made of metal and are reusable after sterilization.

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 04:04:28 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