Sterile fluted surgical drill

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

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Produced at 02.11.2019 at 06:14:14 AEDT

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