f6e51c06-be88-4885-be98-5e487ec52b84UpdatePublished42021-04-072016-09-24In Commercial DistributionB324MF600BHC0PrimaryHIBCCMaxiFlex Holmium Laser Fiber MF 600BH C198887072MAXIFLEX, LLC1550 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers. truefalsefalsefalsefalsetruetruetruetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK01330000047785Urogenital 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 InstrumentOuter DiametertruetrueEthylene Oxide