a2ce295b-6cc7-4426-8bff-8bec3bc94ffdUpdatePublished32018-07-062015-10-06In Commercial Distribution00836462003019PrimaryGS1SilverSpeed103-0601-200103-0601-200826110710Micro Therapeutics, Inc.110 Hydrophilic GuidewirefalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(508)261-8000covidien.udi@covidien.comK98254300035094Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.falseActiveDQXWIRE, GUIDE, CATHETERLengthDevice Size Text, specifyGuidewire,.010,Inch;Storage Environment TemperatureSpecial Storage Condition, SpecifyAvoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHTtruefalse