Upper-limb

Main information

  • Trade name:
  • Upper-limb traction wrap
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Upper-limb traction wrap
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216276
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216276

Medsell Sales Pty Ltd T/A Denyers International - Upper-limb traction wrap

ARTG entry for

Medical Device Included Class Is

Sponsor

Denyers Pty Ltd T/a Denyers International

Postal Address

44-46 Nelson Street,MOORABBIN, VIC, 3189

Australia

ARTG Start Date

21/10/2013

Product category

Medical Device Class Is

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

Phase 2 Medical Manufacturing Inc

88 Airport Drive

Rochester, NH, 03867-0550

United States Of America

Products

1. Upper-limb traction wrap

Product Type

Single Device Product

Effective date

21/10/2013

GMDN

58817 Upper-limb traction wrap

Intended purpose

A sterile preformed device designed to encompass the fingers to create a holder which can be attached to

an external frame to provide traction/suspension during surgical procedures. It is typically made of

synthetic polymer textile (e.g., nylon). This is a single-use 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 02.12.2017 at 05:07:12 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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