Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Halyard Australia Pty Ltd - Surgical procedure kit, neurosurgical, single-use, non-medicated
ARTG entry for
Medical Device Included Class IIb
Halyard Australia Pty Ltd
PO Box 385,MILSONS POINT, NSW, 1565
ARTG Start Date
Medical Device Class IIb
- 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.
Halyard Health Inc
5405 Windward Parkway
Alpharetta, GA, 30004
United States Of America
1. Surgical procedure kit, neurosurgical, single-use, non-medicated
Medical device system
44063 Surgical procedure kit, neurosurgical, single-use, non-medicated
The medical device is indicated for use to create RF lesions in nervous tissue. This device is also indicated
for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe
No Specific Conditions included on Record
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Produced at 03.11.2017 at 05:01:00 AEDT
This is not an ARTG Certificate document.
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