Drill

Main information

  • Trade name:
  • Drill handpiece, surgical, gas-powered
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Drill handpiece, surgical, gas-powered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220413
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220413

C R Kennedy & Co Pty Ltd - Drill handpiece, surgical, gas-powered

ARTG entry for

Medical Device Included Class IIa

Sponsor

C R Kennedy & Co Pty Ltd

Postal Address

PO Box 82,PORT MELBOURNE, VIC, 3207

Australia

ARTG Start Date

24/02/2014

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

AS Medizintechnik GmbH

Sattlerstrasse 15

Tuttlingen, , 78532

Germany

Products

1. Drill handpiece, surgical, gas-powered

Product Type

Single Device Product

Effective date

24/02/2014

GMDN

37876 Drill handpiece, surgical, gas-powered

Intended purpose

A hand-held device used in orthopaedic surgery for the purpose of drilling/cutting/inserting procedures. It

includes a built-in motor and a chuck for attaching/using drills, bone taps or wires. The device may be of

the micro or macro design. It is powered by compressed gas according to the manufacturer's specification.

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 23.11.2017 at 03:48:11 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.