Line-powered

Main information

  • Trade name:
  • Line-powered surgical power tool electrical connection cable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Line-powered surgical power tool electrical connection cable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219753
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219753

Stryker Australia Pty Ltd - Line-powered surgical power tool electrical connection cable

ARTG entry for

Medical Device Included Class 1

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

30/01/2014

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

Stryker Instrument

4100 East Milham Avenue

KALAMAZOO, Michigan, 49001-6797

United States Of America

Products

1. Line-powered surgical power tool electrical connection cable

Product Type

Single Device Product

Effective date

30/01/2014

GMDN

47857 Line-powered surgical power tool electrical connection cable

Intended purpose

Intended to provide the power connection to the mill from a console.

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 06:41:52 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

15-11-2018

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Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

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Europe - EFSA - European Food Safety Authority Publications

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Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

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Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

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23-10-2018

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18-10-2018

CTG recalls Friction Powered School Bus

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Health Canada

11-10-2018

Cooper Lighting LLC Recalls All-Pro and Defiant Solar/Battery Powered Light Fixtures

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11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

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10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

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26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

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Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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Health Canada

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

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20-9-2018

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

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14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

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11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

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Europe - EFSA - European Food Safety Authority Publications

10-9-2018

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6-9-2018

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30-8-2018

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28-8-2018

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26-7-2018

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21-7-2018

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FDA - U.S. Food and Drug Administration

13-7-2018

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FDA - U.S. Food and Drug Administration

28-6-2018

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22-6-2018

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Health Canada

8-6-2018

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Health Canada

5-6-2018

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

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FDA - U.S. Food and Drug Administration

1-6-2018

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FDA - U.S. Food and Drug Administration

1-6-2018

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FDA - U.S. Food and Drug Administration

1-6-2018

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26-5-2018

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FDA - U.S. Food and Drug Administration

10-5-2018

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FDA - U.S. Food and Drug Administration

9-5-2018

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FDA - U.S. Food and Drug Administration

16-4-2018

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Danish Medicines Agency

21-2-2018

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FDA - U.S. Food and Drug Administration

25-1-2018

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FDA - U.S. Food and Drug Administration

3-4-2017

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Danish Medicines Agency

12-12-2016

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Danish Medicines Agency

22-9-2016

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Danish Medicines Agency

28-5-2014

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Danish Medicines Agency

27-3-2012

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Danish Medicines Agency

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

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Europe -DG Health and Food Safety

31-7-2018

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Therapeutic Goods Administration - Australia

30-7-2018

Special Access Scheme online system

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Therapeutic Goods Administration - Australia

27-7-2018

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Therapeutic Goods Administration - Australia

5-7-2018

Scientific guideline:  Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

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2-7-2018

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Therapeutic Goods Administration - Australia

2-7-2018

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Therapeutic Goods Administration - Australia

28-6-2018

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FDA - U.S. Food and Drug Administration

27-6-2018

Regulatory and procedural guideline:  Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product

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23-4-2018

GMP clearance process improvements - Post implementation update

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Therapeutic Goods Administration - Australia

6-4-2018

EU/3/12/1072 (Le4D Limited)

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EU/3/12/1072 (Active substance: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor) - Transfer of orphan designation - Commission Decision (2018)2008 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/11/T/01

Europe -DG Health and Food Safety