Instrument

Main information

  • Trade name:
  • Instrument track/locking tag
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Instrument track/locking tag
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220002
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220002

Paragon Medical Pty Ltd - Instrument track/locking tag

ARTG entry for

Medical Device Included Class 1

Sponsor

Paragon Medical Pty Ltd

Postal Address

PO Box 1964,Scoresby, VIC, 3179

Australia

ARTG Start Date

10/02/2014

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

Clinipak Ltd

Beech House Knaves Beech Business Centre

Davies Way

Loudwater, High Wycombe, HP10 9SD

Products

1. Instrument track/locking tag

Product Type

Single Device Product

Effective date

10/02/2014

GMDN

47823 Instrument track/locking tag

Intended purpose

A non-sterile, colour-coded, tamper evident tag/lock that is attached to a device [e.g., an instrument, trolley

(cart), tray, container or cabinet] to typically indicate operational status, device identification and/or

ownership. It may have a writable label and/or pre-printed message text.

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 05:43:26 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

There are no safety alerts related to this product.

25-5-2018

Section 23 instruments

Section 23 instruments

Section 23 instruments for assessed listed medicines, registered complementary medicines and medicines listed applications.

Therapeutic Goods Administration - Australia

25-5-2018

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

I, Larry Kelly, Acting Deputy Secretary, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23C of the Therapeutic Goods Act 1989, make the following instrument under paragraphs 23C(2)(a...

Therapeutic Goods Administration - Australia

2-5-2018

Section 22 instruments

Section 22 instruments

The following instruments are made under section 22 of the Therapeutic Goods Act 1989

Therapeutic Goods Administration - Australia