Summary for ARTG Entry:
Big Green Surgical Company Pty Ltd - Electronic general cryosurgical system
ARTG entry for
Medical Device Included Class IIb
Big Green Surgical Company Pty Ltd
46 Albert Street,PRESTON, VIC, 3072
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.
Galil Medical Inc
4364 Round Lake Road
Arden Hills, MN, 55112
United States Of America
1. Electronic general cryosurgical system
Medical device system
45738 Electronic general cryosurgical system
The Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally
invasive, transient surgical procedures. The System is indicated for use as a cryosurgical tool in the fields
of general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and
urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases,
tumors, skin lesions, and warts) by the application of extremely cold temperatures.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:57:57 AEDT
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