Dispenser, cement, orthopaedic

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

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Sẵn có từ:
Merit Medical Australia Pty Ltd
Lớp học:
Class Is
Tình trạng ủy quyền:
Số ủy quyền:

Public Summary

Summary for ARTG Entry:


Merit Medical Australia Pty Ltd - Dispenser, cement, orthopaedic

ARTG entry for

Medical Device Included Class Is


Merit Medical Australia Pty Ltd

Postal Address

63 Wells Road,Chelsea Heights, VIC, 3196


ARTG Start Date


Product category

Medical Device Class Is



Approval area

Medical Devices


- 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.




Merit Medical Systems Inc

1600 West Merit Parkway

South Jordan, UTAH, 84095

United States Of America


1. Dispenser, cement, orthopaedic

Product Type

Single Device Product

Effective date



35809 Dispenser, cement, orthopaedic

Intended purpose

The DiamondTOUCH Syringe is intended for percutaneous delivery of bone cement. The device can also

be used for inflating and deflating interventional devices, and to measure pressure.

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 05:18:03 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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