Home GUDID 00845225002824 Refinity Rotational Intravascular Ultrasound IVUS Catheter
Primary DI 00845225002824
Brand Refinity Rotational Intravascular Ultrasound IVUS Catheter
Company Volcarica S.R.L.
Model 89800
Published 2016-11-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DQO Catheter, Intravascular, Diagnostic OBJ Catheter, Ultrasound, Intravascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQO Catheter, Intravascular, Diagnostic Cardiovascular 2 OBJ Catheter, Ultrasound, Intravascular Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00845225002824 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00845225002824 00845225002824 845225002824 0845225002824
GMDN Terms# Term, Definition table Term Definition Intravascular ultrasound imaging catheter, single-use A 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 either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.
Regulatory Flags# DUNS number 853202646 Device count 1 Serial number true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00845225001100 PrimeWire Prestige Plus Pressure Guide Wire 185cm ST 9185 2016-08-22 00845225001117 PrimeWire Prestige Plus Pressure Guide Wire 185cm JTIP 9185J 2016-08-22 00845225001124 PrimeWire Prestige Plus Pressure Guide Wire 300cm ST 9300 2016-08-22 00845225001131 PrimeWire Prestige Plus Pressure Guide Wire 300cm JTIP 9300J 2016-08-22 00845225001148 PrimeWire Prestige Pressure Guide Wire 185cm ST 8185 2016-08-23 00845225001155 PrimeWire Prestige Pressure Guide Wire 185cm JTIP 8185J 2016-08-22 00845225001162 PrimeWire Prestige Pressure Guide Wire 300cm ST 8300 2016-08-22 00845225001179 PrimeWire Prestige Pressure Guide Wire 300cm JTIP 8300J 2016-08-23 00845225002435 Verrata Pressure Guide Wire 185cm 10185 2016-08-22 00845225002442 Verrata Pressure Guide Wire 185cm JTIP 10185J 2016-08-22 00845225002459 Verrata Pressure Guide Wire 300cm 10300 2016-08-22 00845225002466 Verrata Pressure Guide Wire 300cm JTIP 10300J 2016-08-22 00845225002598 Visions PV .035, 90 CM, US Digital IVUS Catheter 81234 2016-08-23
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