Haemostatic-agent endotherapy cannula

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

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Available from:
Johnson & Johnson Medical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322483

Public Summary

Summary for ARTG Entry:

322483

Johnson & Johnson Medical Pty Ltd - Haemostatic-agent endotherapy cannula

ARTG entry for

Medical Device Included Class IIa

Sponsor

Johnson & Johnson Medical Pty Ltd

Postal Address

PO Box 134,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

30/08/2019

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

Ethicon Inc Also Trading as Ethicon Women's

Health & Urology a Division of Ethicon Inc

PO Box 151 Route 22 West

Somerville, New Jersey, 08876-0151

United States Of America

Products

1. Haemostatic-agent endotherapy cannula

Product Type

Single Device Product

Effective date

30/08/2019

GMDN

52751 Haemostatic-agent endotherapy cannula

Intended purpose

A device intended to be used during a laparoscopic procedure to provide access for the administration of a

haematological concentrate and/or haemostatic agent to a bleeding surgical site, typically to facilitate

haemostasis and healing.

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 05:39:38 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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