Sterile fluted surgical drill

Australië - Engels - Department of Health (Therapeutic Goods Administration)

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Beschikbaar vanaf:
Cingular Orthopaedics International Holdings Limited
klasse:
Class IIa
Autorisatie-status:
Included
Autorisatienummer:
322360

Public Summary

Summary for ARTG Entry:

322360

Cingular Orthopaedics Pty Ltd - Sterile fluted surgical drill

ARTG entry for

Medical Device Included Class IIa

Sponsor

Cingular Orthopaedics Pty Ltd

Postal Address

PO Box 1433,Noosa Heads, QLD, 4567

Australia

ARTG Start Date

27/08/2019

Product category

Medical Device Class IIa

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

Guangzhou Aquila Precise Tools Limited

Jinsiwei Industrial Zone Dachongkou Village

Shawan Town

Paunyu District, Guangzhou City People,

511483

China

Products

1. Sterile fluted surgical drill

Product Type

Single Device Product

Effective date

27/08/2019

GMDN

43390 Sterile fluted surgical drill

Intended purpose

C-Pinsurgical instruments are designed to perform specific

functions such as pinning, cutting and drilling.

C-Pinsurgical instruments may also be used to facilitate the

insertion of surgical implants.

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 05:54:35 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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