53ef0bb0-a0bb-4949-86f2-dade2798c7e1UpdatePublished22024-01-012023-07-11In Commercial DistributionB35400Unit of UseHIBCCB354OSM45DB5PrimaryHIBCCMaryland Dissector 45 degree 44cm Bariatric Fully DisposableOSM45DB047063695ORANGE SURGICAL INSTRUMENTS, LLC90Maryland Dissector 45 degree 44cm Bariatric Fully DisposablefalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK10173300061875Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.falseActiveGEIElectrosurgical, Cutting & Coagulation & Accessoriestruefalse