B-D PEN ULTRA

B-D PEN ULTRA is an FDA 510(k)-cleared medical device (K981797) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. 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 11, 1998. Regulation: 8.