ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER

ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER is an FDA 510(k)-cleared medical device (K081449) manufactured by Ultimed, 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 June 2, 2008. Regulation: 8.