
The Ludlow Company LP
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UNI-PATCH ULTRASOUND COUPLING GEL is an FDA 510(k)-cleared medical device (K021132) manufactured by The Ludlow Company LP. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2002. Regulation: 8.