Wire

Main information

  • Trade name:
  • Wire holding/twisting pliers
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Wire holding/twisting pliers
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220208
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220208

Ausmedical Pty Ltd - Wire holding/twisting 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. Wire holding/twisting pliers

Product Type

Single Device Product

Effective date

17/02/2014

GMDN

32874 Wire holding/twisting pliers

Intended purpose

A heavy-duty, surgical instrument with specially designed sturdy handles and blade jaws used to grip,

tighten and/or twist wires that are being applied to the patient 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 short and broad with serrations) at the working end may be pivoted or have a

ratio-lever exchange 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 04:54:30 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

27-9-2018

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

18-6-2018

June 15, 2018: Theranos Founder and Former Chief Operating Officer Charged in Alleged Wire Fraud Schemes

June 15, 2018: Theranos Founder and Former Chief Operating Officer Charged in Alleged Wire Fraud Schemes

June 15, 2018: Theranos Founder and Former Chief Operating Officer Charged in Alleged Wire Fraud Schemes

FDA - U.S. Food and Drug Administration

18-5-2018

MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use

MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use

There is a risk of the delivery wire breaking or separating during use. The clot retriever could be left inside the patient's bloodstream, and this or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death.

FDA - U.S. Food and Drug Administration

There are no news related to this product.