2 results
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12ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 8, 2014
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·March 1, 2017