336c2897-155e-43ae-b0ea-2606f19430c9UpdatePublished22024-02-292024-01-092024-02-28Not in Commercial DistributionG460SP1010PrimaryHIBCCAURASP101SP101063237649Branchpoint & Aura Development LLC1AURA™ Sensor TrayfalsefalsefalsetruefalsetruetruetruetruetruefalsefalsefalseMR Unsafetruefalse909-278-7062info@branchpointmed.comK17220900061398Intracerebral sensor catheter, short-termA flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.falseActiveGWMDevice, Monitoring, Intracranial PressureStorage Environment HumidityStorage Environment TemperatureStorage Environment Atmospheric Pressuretruefalse