e0a1b84f-452e-448e-a7fe-5309902574c9UpdatePublished42021-04-072016-09-29In Commercial Distribution04059497000433PackageGS10405949700019810In Commercial Distribution04059497000198PrimaryGS1FiberTech®FT IR600/720HCN-3/SL-SF-1750 003711CM280202S342703174LEONI Fiber Optics GmbH1falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK05073800047785Urogenital surgical laser system beam guide, single-useA flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.falseActiveGEXPowered laser surgical instrumenttruefalse