31275c58-b930-43de-be81-8cf3f4d58860UpdatePublished22018-03-292017-01-31In Commercial Distribution04049089200280PackageGS1040490891002835In Commercial DistributionBox04049089100283PrimaryGS1Endovascular Laser Vein System (ELVeS®) KitELVeS® Radial® Kit 6Fx7cm101235506069240Ceram Optec SIA1falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse47535Varicose vein lasing procedure kitA collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer sheath, a catheter, a guidewire, a dilator, and connectors to facilitate connection to a laser (e.g., a diode laser) and provide a pathway for the laser energy into the section(s) of the vein to be treated. This device does not contain pharmaceuticals. This is a single-use device.falseActiveGEXPowered Laser Surgical Instrumenttruefalse