Ultrasonic surgical system generator

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

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Доступна з:
Stryker Australia Pty Ltd
Клас:
Class 1
Статус Авторизація:
Included
Кількість Авторизація:
324074

Public Summary

Summary for ARTG Entry:

324074

Stryker Australia Pty Ltd - Ultrasonic surgical system generator

ARTG entry for

Medical Device Included Class 1

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

26/09/2019

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

Stryker Instruments

4100 East Milham Avenue

Kalamazoo, MI, 49001

United States Of America

Products

1. Ultrasonic surgical system generator

Product Type

Single Device Product

Effective date

26/09/2019

GMDN

36273 Ultrasonic surgical system generator

Intended purpose

Intended for use with the Ultrasonic surgical system generator to control settings level of system functional

outputs.

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 03:40:59 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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