Bur

Main information

  • Trade name:
  • Bur, cranial
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bur, cranial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217639
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217639

C R Kennedy & Co Pty Ltd - Bur, cranial

ARTG entry for

Medical Device Included Class 1

Sponsor

C R Kennedy & Co Pty Ltd

Postal Address

PO Box 82,PORT MELBOURNE, VIC, 3207

Australia

ARTG Start Date

22/11/2013

Product category

Medical Device Class 1

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. Bur, cranial

Product Type

Single Device Product

Effective date

22/11/2013

GMDN

10520 Bur, cranial

Intended purpose

A small rotary shaft of steel or other hard metal with fluting or cutting planes of various shapes on one end

used to excavate soft or hard skull tissue. This device is inserted into an appropriate powered device to

provide the rotation.

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 03:56:15 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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