Olympus MDFS100 Diego Elite Footswitch, NEW

The Olympus MDFS100 Diego Elite Footswitch is a footswitch accessory used for hands-free control of the Diego Elite electrosurgical system. Condition: New Specifications: - Manufacturer: Gyrus ACMI, LLC (Olympus) - Brand Name: Diego Elite - Model / Version: MDFS100 - Device Description: Diego Elite Footswitch - GMDN Code: 44776 - GMDN Term: Electrosurgical system - Product Code: GEI - Product Code Name: Electrosurgical, Cutting & Coagulation & Accessories - Device Class: 2 - Regulation Number: 878.4400 - Premarket Submission: K123429 - UDI (Primary): 00821925027787 (GS1) - Quantity per Package: 1 The MDFS100 is a footswitch component designed for use with the Diego Elite platform, which is classified as an electrosurgical system for cutting and coagulation during endoscopic or open surgical procedures. The footswitch enables hands-free activation of the system, allowing the surgeon to maintain instrument control at the operative site. This device is listed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), Class II, under regulation 21 CFR 878.4400, with premarket clearance K123429. It is manufactured by Gyrus ACMI, LLC and carries a GS1 primary UDI of 00821925027787. Features: - Hands-free control interface for the Diego Elite electrosurgical platform - Compatible with Diego Elite system (Gyrus ACMI / Olympus) - FDA Class II device under 21 CFR 878.4400 - Single unit per package Applications: - Hands-free activation of RF cutting and coagulation during endoscopic procedures - Hands-free activation of RF cutting and coagulation during open surgical procedures - ENT surgical procedures utilizing the Diego Elite system WARRANTY/RETURNS: -No warranty is expressed or implied with the sale of this item(s). -Buyer has 14 days to return or exchange (if inventory allows) the product(s). Buyer is responsible for all and any shipping costs/fees. Product must be returned in original, sterile, sealed packaging. "The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."