95ceb856-1811-4943-9710-c52e3ff9d092NewPublished12022-09-302022-09-22In Commercial DistributionM735B5777045PackageHIBCCM735B577704110In Commercial DistributionM735B5777041PrimaryHIBCCNAB577704791553436OPHTHALMED LLC1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse7707776613info@ophthalmed.comK05080700061162Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.falseActiveHQFLaser, OphthalmicNeedle Gaugetruefalse