STERRAD(R) 100NX STERILIZER DUO CYCLE

STERRAD(R) 100NX STERILIZER DUO CYCLE is an FDA 510(k)-cleared medical device (K111377) manufactured by Advanced Sterilization Products. 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 September 12, 2012. Regulation: 8.