Instrument/equipment drape, single-use

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Australian Medical Supplies Pty Ltd
Class:
Class Is
Authorization status:
Included
Authorization number:
292774

Read the complete document

Public Summary

Summary for ARTG Entry:

292774

Australian Medical Supplies Pty Ltd - Instrument/equipment drape, single-use

ARTG entry for

Medical Device Included Class Is

Sponsor

Australian Medical Supplies Pty Ltd

Postal Address

PO Box 5587,FALCON, WA, 6210

Australia

ARTG Start Date

14/08/2017

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

Medical Technique Inc

8060 E Research Ct

Tucson, Arizona, 85710

United States Of America

Products

1. Instrument/equipment drape, single-use

Product Type

Single Device Product

Effective date

14/08/2017

GMDN

45021 Instrument/equipment drape, single-use

Intended purpose

A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated

protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray,

operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and

lasers], to provide a barrier against cross-contamination in various clinical settings. 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 03.11.2017 at 07:21:39 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

Search alerts related to this product

Share this information