Gyrus ACMI MR-6LA Bagley Semi-Rigid Ureteroscope

The Gyrus ACMI MR-6LA Bagley Self-Dilating Autoclavable Semi-Rigid Ureteroscope is a rigid optical ureteroscope used for visual examination and treatment of the ureter. Condition: Refurbished Specifications: - Manufacturer: Gyrus ACMI, LLC - Model Number: MR-6LA - Brand Name: Bagley - Device Type: Semi-Rigid Ureteroscope - GMDN Code: 36654 – Rigid Optical Ureteroscope - Product Code: FGB – Ureteroscope and Accessories, Flexible/Rigid - Device Class: II - Regulation Number: 876.1500 - Premarket Submission: K052044 - UDI (Primary): 00821925006232 (GS1) - Medical Specialty: Gastroenterology, Urology - Has Serial Number: Yes The MR-6LA features a self-dilating design and is constructed for autoclavable reprocessing, supporting repeated clinical use. It is inserted through the external urethral orifice and advanced through the bladder to access the ureter, with anatomical images transmitted to the user via relayed lens optics or a fibreoptic bundle. This instrument is indicated for a range of ureteroscopic procedures including biopsy, endoscopic lithotripsy, management of upper urinary tract malignancies, incision of strictures, and repair of ureteropelvic junction obstructions. It is classified as a Class II device under FDA regulation 876.1500 and cleared under premarket submission K052044. Features: - Self-dilating design for ureteroscopic access - Autoclavable construction supporting reuse - Semi-rigid inserted portion for ureter navigation - Relayed lens optics or fibreoptic bundle image transmission - Serialized device with manufacturing date tracking Applications: - Visual examination of the ureter and upper urinary tract - Endoscopic lithotripsy - Biopsy of upper urinary tract tissue - Treatment of upper urinary tract malignancies - Incision of ureteral strictures - Repair of ureteropelvic junction obstructions 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."