Surgical procedure kit, general-purpose, single-use, non-medicated

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

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Available from:
Thermo Fisher Scientific Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
293298

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Public Summary

Summary for ARTG Entry:

293298

Thermo Fisher Scientific Australia Pty Ltd - Surgical procedure kit, general-purpose, single-use,

non-medicated

ARTG entry for

Medical Device Included Class IIb

Sponsor

Thermo Fisher Scientific Australia Pty Ltd

Postal Address

PO Box 9092,SCORESBY, VIC, 3179

Australia

ARTG Start Date

29/08/2017

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

Lovell Surgical Supplies International Pty Ltd

Unit 4 28-30 Silkwood Rise

CARRUM DOWNS, VIC, 3201

Australia

Products

1. Surgical procedure kit, general-purpose, single-use, non-medicated

Product Type

Procedure Pack

Effective date

29/08/2017

GMDN

33961 Surgical procedure kit, general-purpose, single-use, non-medicated

Intended purpose

The general purpose surgical procedure packs are custom made surgical procedure pack used in an

general surgical procedures

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 05:12:24 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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