
Advanced Sterilization Products, Inc.
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STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) is an FDA 510(k)-cleared medical device (K234084) manufactured by Advanced Sterilization Products, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 4, 2024. Regulation: 8.

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