IDRIVE ULTRA STERILIZATION TRAY

IDRIVE ULTRA STERILIZATION TRAY is an FDA 510(k)-cleared medical device (K130532) manufactured by Covidien, Formerly US Surgical A Divison of Tyco H. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2013. Regulation: 8.