Drill

Main information

  • Trade name:
  • Drill bit, surgical
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Drill bit, surgical
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217013
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217013

Wright Medical Australia Pty Ltd - Drill bit, surgical

ARTG entry for

Medical Device Included Class IIa

Sponsor

Wright Medical Australia Pty Ltd

Postal Address

Unit 5 and 6,15A Rodborough Road,Frenchs Forest, NSW, 2086

Australia

ARTG Start Date

7/11/2013

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

Wright Medical UK Ltd

18 Amor Way

Letchworth Garden City, Hertfordshire,

Products

1. Drill bit, surgical

Product Type

Single Device Product

Effective date

7/11/2013

GMDN

32390 Drill bit, surgical

Intended purpose

A device that is mounted into a surgical drilling machine, either manual or powered, and that, when rotated

at an appropriate speed, will cut into bone creating a hole of the same dimension as the diameter of the

bit.

Specific Conditions

No Specific Conditions included on Record

© 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 10.11.2017 at 03:37:29 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

1-11-2018

Stanley Black & Decker Canada Corp. recalls certain Porter-Cable and Black & Decker hammer drills

Stanley Black & Decker Canada Corp. recalls certain Porter-Cable and Black & Decker hammer drills

The side handle supplied with the drill may slip when the drill is in use and lead to loss of control, posing a risk of injury.

Health Canada

There are no news related to this product.