Retractor

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220119
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220119

Medical & Optical Instruments Australia Pty Ltd - Retractor, general-purpose, self-retaining

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medical & Optical Instruments Australia Pty Ltd

Postal Address

PO Box 850,ARTARMON, NSW, 1570

Australia

ARTG Start Date

13/02/2014

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

Thompson Surgical Instruments Inc

10170 East Cherry Bend Road

Transverse City, Michigan, 49684

United States Of America

Products

1. Retractor, general-purpose, self-retaining

Product Type

Single Device Product

Effective date

13/02/2014

GMDN

45182 Retractor, general-purpose, self-retaining

Intended purpose

A self-locking instrument used to temporarily part tissue or other anatomical structures, to expose internal

tissues or organs for access during surgery The retractors are either blunt or hook-like, with multiple

wide-angle blades in a variety of forms. It is made of metal and is 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 05:13:40 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