Ultravision

Main information

  • Trade name:
  • Ultravision System - Evacuator, smoke, surgical
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ultravision System - Evacuator, smoke, surgical
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222142
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222142

MD Solutions Australasia Pty Ltd - Ultravision System - Evacuator, smoke, surgical

ARTG entry for

Medical Device Included Class IIb

Sponsor

MD Solutions Australasia Pty Ltd

Postal Address

Unit 1/16-18 Tennyson Street,WILLIAMSTOWN NORTH, VIC, 3016

Australia

ARTG Start Date

8/04/2014

Product category

Medical Device Class IIb

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

Asalus Medical Instruments Ltd

Suite 18 Cardiff Medicentre

Cardiff, Wales, CF14 4UJ

Products

1. Ultravision System - Evacuator, smoke, surgical

Product Type

Medical device system

Effective date

8/04/2014

GMDN

37861 Evacuator, smoke, surgical

Intended purpose

Indicated for the clearance of smoke and other particulate matter that is created during laparoscopic

surgery by monopolar, bipolar and ultrasonic instruments.

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 10:38:55 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