cb644411-5e35-4a96-aaaf-689ebc4c9737UpdatePublished62023-06-162017-10-052023-06-15Not in Commercial Distribution08033945937478PackageGS10803394593737922023-06-15Not in Commercial Distributioncarton box08033945937379PackageGS10803394593726352023-06-15Not in Commercial Distributioncarton box08033945937263PrimaryGS1Single Use Surgical Optical Fiber 09-0051436045833QUANTA SYSTEM SPA1Single Use Surgical Optical Fiber ø 550 µm Distributed by Cogentix.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse47785Urogenital 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