BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR

BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR is an FDA 510(k)-cleared medical device (K851470) manufactured by Lic-Orthion. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 1985. Regulation: 8.