
Keilei Intl., Inc.
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X-RAY DETECTABLE GAUZE SPONGE is an FDA 510(k)-cleared medical device (K895372) manufactured by Keilei Intl., Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 2, 1989. Regulation: 8.