Tourniquet

Main information

  • Trade name:
  • Tourniquet, pneumatic
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tourniquet, pneumatic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219406
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219406

Zimmer Pty Ltd - Tourniquet, pneumatic

ARTG entry for

Medical Device Included Class IIb

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

21/01/2014

Product category

Medical Device Class IIb

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

Zimmer Surgical Inc

200 West Ohio Avenue

Dover, Ohio, 44622-0010

United States Of America

Products

1. Tourniquet, pneumatic

Product Type

Single Device Product

Effective date

21/01/2014

GMDN

14074 Tourniquet, pneumatic

Intended purpose

An electrically powered Pneumatic Tourniqet used to temporarily occlude blood flow in a patient's

extremities during surgical procedures on those extremities.

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 07:41:00 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

25-5-2018

Urgent Medical Device Recall: Sam XT Extremity Tourniquet

Urgent Medical Device Recall: Sam XT Extremity Tourniquet

SAM Medical today announced it is conducting a voluntary international recall of all unused SAM XT Extremity Tourniquets (SAM XT). The company initiated the recall after internal testing indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. To date, there have been no reports of adverse health consequences received. This recall is being made with the knowledge of the Food and Drug A...

FDA - U.S. Food and Drug Administration

There are no news related to this product.