Summary for ARTG Entry:
Biotronik Australia Pty Ltd - Instrument/equipment drape, single-use
ARTG entry for
Medical Device Included Class Is
Biotronik Australia Pty Ltd
Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073
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.
TIDI Products LLC
14241 Fenton Road
Fenton, Michigan, 48430
United States Of America
1. Instrument/equipment drape, single-use
Single Device Product
45021 Instrument/equipment drape, single-use
A sterile, single-use drape made of synthetic materials intended to be used as a protective covering for the
shielding element of the ZeroGravity Radiation Protection System, to provide a barrier against
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 12:15:43 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