Guard

Main information

  • Trade name:
  • Guard, instrument
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Guard, instrument
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218664
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218664

Medical & Optical Instruments Australia Pty Ltd - Guard, instrument

ARTG entry for

Medical Device Included Class 1

Sponsor

Medical & Optical Instruments Australia Pty Ltd

Postal Address

PO Box 850,ARTARMON, NSW, 1570

Australia

ARTG Start Date

18/12/2013

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

Key Surgical Inc

8101 Wallace Road

Eden Prairie, Minnesota, 55344

United States Of America

Products

1. Guard, instrument

Product Type

Single Device Product

Effective date

18/12/2013

GMDN

34004 Guard, instrument

Intended purpose

A surgical instrument accessory used to protect the user and/or instrument to which it is applied from harm

or damage. Some guards are instrument specific

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 09:46:18 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

12-3-2019

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA - U.S. Food and Drug Administration

29-11-2018

ANSES and CEA join forces to strengthen technological innovation in order to safeguard health

ANSES and CEA join forces to strengthen technological innovation in order to safeguard health

During the symposium organised to mark the sixtieth anniversary of the creation of the ANSES Laboratory in Ploufragan (Côtes d'Armor), on Thursday 29 November 2018, Roger Genet, Director General of ANSES, and Stéphane Siebert, Director of Technological Research at the CEA, signed a framework partnership agreement aimed at strengthening their cooperation to develop innovative technological tools in order to improve responsiveness in the fields of animal and plant health and food safety.

France - Agence Nationale du Médicament Vétérinaire

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

30-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

FDA warns doctors and patients about deceptive claims on laser medical devices used to treat menopausal symptoms for “vaginal rejuvenation”

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

24-5-2018

Three questions for Gilles Salvat, ANSES Managing Director General for Research and Reference

Three questions for Gilles Salvat, ANSES Managing Director General for Research and Reference

As Reference Delegation Day is held at ANSES, bringing together representatives of national and European reference laboratories, Gilles Salvat, Managing Director General for Research and Reference, gives us an overview of this essential part of ANSES's work. What do you mean by reference? Reference is an essential component of the system for safeguarding health. The work of the reference laboratories is vital to improving knowledge and identification of the major hazards we face in food safety, animal...

France - Agence Nationale du Médicament Vétérinaire

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

14-12-2018

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here:  https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2

FDA - U.S. Food and Drug Administration

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency