STERIGAGE MODEL 1243RA, 1243RB, 1243RE

STERIGAGE MODEL 1243RA, 1243RB, 1243RE is an FDA 510(k)-cleared medical device (K101249) manufactured by 3M Company. 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 7, 2010. Regulation: 8.