Cast

Main information

  • Trade name:
  • Cast stockinette
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cast stockinette
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217274
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217274

DJO Global Pty Ltd - Cast stockinette

ARTG entry for

Medical Device Included Class 1

Sponsor

DJO Global Pty Ltd

Postal Address

PO Box 2057,NORMANHURST, NSW, 2076

Australia

ARTG Start Date

13/11/2013

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

BL Tech Co Ltd

302 Osan-ri

Dongtan-myeon, Gyeonggi-do, 445-813

Korea - Republic of

Products

1. Cast stockinette

Product Type

Single Device Product

Effective date

13/11/2013

GMDN

10669 Cast stockinette

Intended purpose

Water resistant cast padding

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 02:42:20 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

17-5-2018

Alumilite recalls Amazing Clear Cast

Alumilite recalls Amazing Clear Cast

The recalled products do not have proper consumer chemical hazard packaging and labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

There are no news related to this product.