HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is an FDA 510(k)-cleared medical device (K214007) manufactured by Owens & Minor (O&M) Halyard, 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 July 26, 2022. Regulation: 8.