Summary for ARTG Entry:
Device Technologies Australia Pty Ltd - Endotherapy guidewire, single-use
ARTG entry for
Medical Device Included Class Is
Device Technologies Australia Pty Ltd
Locked Bag 521,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class Is
- 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.
Hochstadt, , 91315
1. Endotherapy guidewire, single-use
Single Device Product
46691 Endotherapy guidewire, single-use
The guide wires are used with flexible endoscopes intended to assist in the cannulation of the biliary and
pancreatic ducts for the introduction of endotherapy devices such as stents, and for the bypassing of
stenoses and strictures during endoscopic procedures.
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 03:40:56 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