Instrument management bag, non-sterile

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

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Available from:
Osstem Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
292097

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Public Summary

Summary for ARTG Entry:

292097

Osstem Australia Pty Ltd - Instrument management bag, non-sterile

ARTG entry for

Medical Device Included Class 1

Sponsor

Osstem Australia Pty Ltd

Postal Address

Suite 3 Level 1 Waterloo Business Park 35-41 Waterloo Road,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

26/07/2017

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

Osung Mnd Co Ltd

57 Hwanggeum-ro 109beon-gil Yangchon-eup

Gimpo-si

, Gyeonggi-do, 415-843

Korea - Republic of

Products

1. Instrument management bag, non-sterile

Product Type

Single Device Product

Effective date

26/07/2017

GMDN

58968 Instrument management bag, non-sterile

Intended purpose

A non-sterile flexible plastic container intended to hold/collect instruments, cables,or other equipment

during a surgical procedure or other clinical intervention, typically being attached to a drape or other

support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g.,

number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device intended

to be sterilized prior to use.

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 10:18:13 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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