7ae4240a-cef4-4783-91df-a45ceabac990UpdatePublished32023-07-132019-03-212023-07-12Not in Commercial DistributionR88901PrimaryHIBCCNES Reprocessed Visions PV .035 Digital IVUS CatheterR-88901R-88901608625823NORTH EAST SCIENTIFIC INC1The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).truefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse203-756-2111info@smarthealth-care.comK18112600064174Intravascular ultrasound imaging catheter, reprocessedA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.falseActiveOWQReprocessed Intravascular Ultrasound CatheterCatheter Working LengthLumen/Inner Diametertruefalse