
Regulatory & Marketing Services, Inc.
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ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG is an FDA 510(k)-cleared medical device (K944378) manufactured by Regulatory & Marketing Services, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 14, 1995. Regulation: 8.