1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 is an FDA 510(k)-cleared medical device (K093400) manufactured by Unilife Medical Solutions Limited. 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 31, 2010. Regulation: 8.