MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229

MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 is an FDA 510(k)-cleared medical device (K100367) manufactured by Origio A/S. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2010. Regulation: 8.