SKYTRON B1-530-10 Center Focus Light Handle with Intensity Control, NEW IN BOX

The SKYTRON Center Focus Handle is a surgical light accessory used for positioning and intensity control of Aurora II, Aurora 3, and Aurora Four operating room lights.

Condition: New

Included Items: One Center Focus Handle

Quantity Included: 1 Unit Specifications: - Manufacturer: SKYTRON LLC - Catalog Number: B1-530-10 - Brand Name: Center Focus Handle - Device Description: Center Focus Handle with Intensity Control for Aurora II, Aurora 3, and Aurora Four Lights - Product Code: FTA – Light, Surgical, Accessories - Device Class: Class II (21 CFR 878.4580) - Medical Specialty: General, Plastic Surgery - GMDN Code: 37332 – Operating Room Light System - Quantity per Package: 1 The SKYTRON B1-530-10 is a center focus handle with integrated intensity control, designed specifically for use with SKYTRON Aurora II, Aurora 3, and Aurora Four surgical light systems. It is classified as a surgical light accessory (FDA product code FTA) under 21 CFR 878.4580 and falls within the Class II medical device category for General and Plastic Surgery applications. This handle is part of an operating room light system platform that provides specialized illumination at the site of medical intervention. The device carries a manufacturing date and lot/batch number for traceability purposes. Features: - Integrated intensity control for adjustable illumination - Compatible with SKYTRON Aurora II, Aurora 3, and Aurora Four light systems - Lot/batch number and manufacturing date for full traceability - Direct marking compliant per GS1 standards Applications: - Surgical light positioning in the operating room - Illumination intensity adjustment during operative procedures - General and plastic surgery environments 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."