Sterile fluted surgical drill

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)

01-11-2019

Saadav alates:
Australian Pacific Medical Pty Ltd
Klass:
Class IIa
Volitamisolek:
Included
Müügiloa number:
322201

Public Summary

Summary for ARTG Entry:

322201

Australian Pacific Medical Pty Ltd - Sterile fluted surgical drill

ARTG entry for

Medical Device Included Class IIa

Sponsor

Australian Pacific Medical Pty Ltd

Postal Address

1 Clanalpine Street,EASTWOOD, NSW, 2122

Australia

ARTG Start Date

23/08/2019

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

Shanghai Bojin Medical Instruments Co Ltd

A Zone of F2 C Zone of F1 Building 6 No 125

Longpan Road

Jiading District, Shanghai, 201801

China

Products

1. Sterile fluted surgical drill

Product Type

Single Device Product

Effective date

23/08/2019

GMDN

43390 Sterile fluted surgical drill

Intended purpose

A sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to

create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist

drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that

extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power

tool or a surgical hand drill/brace. It is typically made of high-grade stainless steel and is available in

various sizes. This is a single-use device.

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 06:14:14 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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