Summary for ARTG Entry:
William A Cook Australia Pty Ltd - Biopsy kit, ultrasonic aspiration
ARTG entry for
Medical Device Included Class IIa
William A Cook Australia Pty Ltd
95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113
ARTG Start Date
Medical Device Class IIa
- 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.
Cook Ireland Ltd
O'Halloran Road National Technology Park
1. Biopsy kit, ultrasonic aspiration
Single Device Product
10403 Biopsy kit, ultrasonic aspiration
The Endobronchial HD Ultrasound Biopsy Needle is used with an ultrasound endoscope for fine needle
biopsy (FNB) of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or
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.
Page 1 of
Produced at 10.11.2017 at 07:16:52 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