255f5a6d-f140-4ce7-8fc7-b8938f2d430bUpdatePublished52022-08-252018-03-072022-08-24Not in Commercial Distribution08033945937997PackageGS10803394593798022022-08-24Not in Commercial Distributioncarton box08033945937980PackageGS10803394593797352022-08-24Not in Commercial Distributioncarton box08033945937973PrimaryGS1Single use Surgical Optical FiberOFH302711EMP-FBX200BHS436045833QUANTA SYSTEM SPA1Single use Surgical Ball tip Optical Fiber ø 272 µm. Distributed by Olympus Surgical Technologies America.Gyrus ACMI, Inc.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK18015800047785Urogenital 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