Summary for ARTG Entry:
Olympus Australia Pty Ltd - Torque manipulating device
ARTG entry for
Medical Device Included Class Is
Olympus Australia Pty Ltd
PO Box 985,MOUNT WAVERLEY, VIC, 3149
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.
Gyrus Acmi Inc
136 Turnpike Road
Southborough, Massachusetts, 01772
United States Of America
1. Torque manipulating device
Single Device Product
46455 Torque manipulating device
A hand-held device that is attached to the proximal end of an invasive device (e.g. a catheter, a needle or
a guidewire) to provide the surgeon with the ability to manipulate and control the directional torque
(rotation) of the device to which it is attached. It may be made of plastic or metal materials and is a
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:56:36 AEDT
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