PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)

PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) is an FDA 510(k)-cleared medical device (K962605) manufactured by Surgicot, Inc.. 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 March 10, 1997. Regulation: 8.