Elastic

Main information

  • Trade name:
  • Elastic bandage
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Elastic bandage
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218947
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218947

Sutherland Medical Pty Limited - Elastic bandage

ARTG entry for

Medical Device Included Class 1

Sponsor

Sutherland Medical Pty Limited

Postal Address

PO Box 1194,HUNTINGDALE, VIC, 3166

Australia

ARTG Start Date

6/01/2014

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

Andover Med Inc

60 Newark Street

Haverhill, MASSACHUSETTS, 01832-1342

United States Of America

Products

1. Elastic bandage

Product Type

Medical device system

Effective date

6/01/2014

GMDN

32214 Elastic bandage

Intended purpose

Coflex bandages are cohesive flexible bandages, of different widths, lengths and colours, of different

tensile strengths, woven and non-woven, used for the stabilisation and support of the musculo-skeletal

system and for compression to soft tissues, can also be used for retention and the treatment of soft tissue

injury such as sprains

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 08:57:23 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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