Sheet

Main information

  • Trade name:
  • Sheet,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sheet,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220003
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220003

Paragon Medical Pty Ltd - Sheet, <specify>

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. Sheet, <specify>

Product Type

Single Device Product

Effective date

10/02/2014

GMDN

13561 Sheet, <specify>

Intended purpose

A device that has the design and shape of an ordinary sheet, usually cloth, dimensioned to fit onto or over

a particular device, person or object. Can be used to line sterilisation trays. Protect wraps from sharp

corners on trays and baskets while also providing rapid absorption of condensate during steam

sterilisation. Often used between layers to facilitate dry packs and assists the steam sterilisation process.

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 05:43:10 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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