Instrument management bag, non-sterile

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

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Osstem Australia Pty Ltd
Class 1
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


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

ARTG entry for

Medical Device Included Class 1


Osstem Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Osung Mnd Co Ltd

57 Hwanggeum-ro 109beon-gil Yangchon-eup


, Gyeonggi-do, 415-843

Korea - Republic of


1. Instrument management bag, non-sterile

Product Type

Single Device Product

Effective date



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

Public Summary

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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.

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