Cannula, arthroscopy drainage

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

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Available from:
Device Technologies Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
339927

Public Summary

Summary for ARTG Entry:

339927

Device Technologies Australia Pty Ltd - Cannula, arthroscopy drainage

ARTG entry for

Medical Device Included Class IIa

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521, FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

21/07/2020

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

Frantz Medical Development Ltd

7740 Metric Drive

Mentor, Ohio, 44060

United States Of America

Products

1 . Cannula, arthroscopy drainage

Product Type

Single Device Product

Effective Date

21/07/2020

GMDN

35620 Cannula, arthroscopy drainage

Intended Purpose

A device used during arthroscopic surgery to establish a path to pass instruments and/or fluid into and out of the surgical site.

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 22.07.2020 at 07:58:30 AEST

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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