Retractor

Main information

  • Trade name:
  • Retractor system, self-retaining
  • Class:
  • Class 1
  • 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:
  • 218170
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218170

Life Healthcare Pty Ltd - Retractor system, self-retaining

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

5/12/2013

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

Life Healthcare Pty Ltd

Level 8 of 15 Talavera Road

NORTH RYDE, NSW, 2113

Australia

Products

1. Retractor system, self-retaining

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

45181 Retractor system, self-retaining

Intended purpose

An assembly of devices used to create a self-locking mechanism to temporarily part tissue or other

anatomical structures, to expose internal tissues or organs for access during surgery. The assembly may

be anchored to the operating room table and may include devices such as horizontal bars, rings, ratchet

mechanisms and a variety of retractor blades. The component parts 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 11:34:06 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