Loupe

Main information

  • Trade name:
  • Loupe, binocular
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Loupe, binocular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222603
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222603

Warner & Webster Pty Ltd - Loupe, binocular

ARTG entry for

Medical Device Included Class 1

Sponsor

Warner & Webster Pty Ltd

Postal Address

PO Box 1150,Huntingdale, VIC, 3166

Australia

ARTG Start Date

16/04/2014

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

Univet SRI

Via Verdi 11

Bergamo, , 24121

Italy

Products

1. Loupe, binocular

Product Type

Medical device system

Effective date

16/04/2014

GMDN

32692 Loupe, binocular

Intended purpose

A system of lenses mounted onto a pair of spectacles worn by the surgeon during surgical intervention.

These function as small telescopes and provide a magnified image of the working field. They can also be

connected to an external light source supplying light directly through the field of vision.

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 09.11.2017 at 08:55:05 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

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

There are no news related to this product.