国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
Integra Neurosciences Pty Ltd
Class III
Integra NeuroSciences Implants SAS 2905 Route Des Dolines, Sophia Antipolis, Cedex, 06921 France
44063 - Surgical procedure kit, neurosurgical, single-use, non-medicated
A bolt in secured through the skull for the introducer which is inserted into the dura for introduction of a separately supplied sensor probe that is part of the Licox monitoring system; and may also be used to introduce an ICP probe through the second lumen of the bolt introducer. A dual lumen bolt introducer for access of the Licox Brain Oxygen Monitoring System that measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. Licox System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern. May also be used to provide access for ICP monitoring.
A
2014-01-06