e4e5207d-5ae5-4071-9b95-a2e9565b6137UpdatePublished52021-10-262014-08-262019-02-06Not in Commercial DistributionM2045500080PrimaryHIBCCSightRail™550-008550-008151047370Spectranetics Corporation1SightRail™ Manual Dilator Sheath falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-800-633-0960complaints@spnc.comK13363100038128Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.falseActiveDREDilator, Vessel, For Percutaneous CatheterizationLumen/Inner DiameterStorage Environment TemperaturetruetrueEthylene Oxide