Summary for ARTG Entry:
Penumbra Neuro Australia Pty Ltd - Catheter controller, steering unit
ARTG entry for
Medical Device Included Class Is
Penumbra Neuro Australia Pty Ltd
Suite 3 Level 5 / 1 Oxford Street,DARLINGHURST, NSW, 2010
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.
One Penumbra Place
Alameda, CA, 94502
United States Of America
1. Catheter controller, steering unit
Single Device Product
31742 Cardiac mapping system workstation
A detachment handle that is attached to the Ruby Coil that when activated releases the embolization coil
into the designated anatomy. This handle is specifically designed for use with the Penumbra Ruby Coil. It
is supplied sterile and is single use.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:00:21 AEDT
This is not an ARTG Certificate document.
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