Surgical instrument fibreoptic light

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
KT Medical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
290426

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Public Summary

Summary for ARTG Entry:

290426

KT Medical Pty Ltd - Surgical instrument fibreoptic light

ARTG entry for

Medical Device Included Class IIa

Sponsor

KT Medical Pty Ltd

Postal Address

262 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

19/06/2017

Product category

Medical Device Class IIa

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

Lumitex Medical Devices Inc

8443 Dow Circle

Strongsville, OH, 44136

United States Of America

Products

1. Surgical instrument fibreoptic light

Product Type

Single Device Product

Effective date

19/06/2017

GMDN

48036 Surgical instrument fibreoptic light

Intended purpose

A sterile, single use device, intended to conduct cold light from a connected fibreoptic light cable and light

source into a surgical wound for illumination during a surgical intervention.

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 03.11.2017 at 04:11:48 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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