Bag, tissue extraction

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

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Available from:
Multigate Medical Products Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
324262

Public Summary

Summary for ARTG Entry:

324262

Multigate Medical Products Pty Ltd - Bag, tissue extraction

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Multigate Medical Products Pty Ltd

Postal Address

27 Llewellyn Avenue,VILLAWOOD, NSW, 2163

Australia

ARTG Start Date

1/10/2019

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

Multigate Co Ltd

No 7 Lanjiang Road

Shaoxing, , 312000

China

Products

1. Bag, tissue extraction

Product Type

Single Device Product

Effective date

1/10/2019

GMDN

45130 Bag, tissue extraction

Intended purpose

A device used during minimal invasive surgery intended for the extraction of dissected tissue typically

involving keyhole surgery techniques. The device is inserted into the body through a large bore cannula

port and the tissue to be extracted is placed in the open bag by other instruments and withdrawn through

the port.

Specific Conditions

© 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 02.11.2019 at 03:15:11 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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