
Unipack Medical Corporation
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UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is an FDA 510(k)-cleared medical device (K183263) manufactured by Unipack Medical Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2019. Regulation: 8.