Surgical

Main information

  • Trade name:
  • Surgical flat-nosed pliers
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Surgical flat-nosed pliers
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220205
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220205

Ausmedical Pty Ltd - Surgical flat-nosed pliers

ARTG entry for

Medical Device Included Class 1

Sponsor

Ausmedical Pty Ltd

Postal Address

8/103 Garden Road,CLAYTON, VIC, 3168

Australia

ARTG Start Date

17/02/2014

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

Tekno-Medical Optik-Chirurgie GmbH

Sattlerstrasse 11

Tuttlingen, , 78532

Germany

Products

1. Surgical flat-nosed pliers

Product Type

Single Device Product

Effective date

17/02/2014

GMDN

44539 Surgical flat-nosed pliers

Intended purpose

A heavy-duty, surgical instrument with specially designed sturdy handles and gripping jaws (typically

parallel) used to grip and hold an object during a surgical intervention. It has a scissors-like design with

curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws

(typically broad with serrations) at the working end are activated through a single pivot or a double

ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.

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 04:55:17 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

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