Medical equipment drape, single-use, non-sterile

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

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Available from:
Dentsply Sirona Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
321831

Public Summary

Summary for ARTG Entry:

321831

Dentsply Sirona Pty Ltd - Medical equipment drape, single-use, non-sterile

ARTG entry for

Medical Device Included Class 1

Sponsor

Dentsply Sirona Pty Ltd

Postal Address

11-21 Gilby Road,Mt Waverley, VIC, 3149

Australia

ARTG Start Date

15/08/2019

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

Dentsply LLC Professional Division t/a Dentsply

Professional t/a Dentsply Pharmaceutical t/a

DENTSPLY RINN

1301 Smile Way

York, Pennsylvania, 17404

United States Of America

Products

1. Medical equipment drape, single-use, non-sterile

Product Type

Single Device Product

Effective date

15/08/2019

GMDN

63712 Medical equipment drape, single-use, non-sterile

Intended purpose

Intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile

and intended for single patient use only.

Specific Conditions

© 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 02.11.2019 at 06:50:25 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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