
Coloplast A/S
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RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM is an FDA 510(k)-cleared medical device (K140523) manufactured by Coloplast A/S. 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 July 23, 2014. Regulation: 8.