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Regulatory Compliance:

FDA Clearance
The patented ONE TRAY® Sealed Container System is 510(K) cleared to rapidly sterilize a 25 pound gross weight load in a pre-vacuum cycle @ 270°F in just 4 minutes (K052567).

ONE TRAY® is the first sealed container to pass all of the rapid sterilization requirements of the FDA #1388 guidance document.

ONE TRAY® Sealed Containers combined with 'Rapid Processing Solution' form a Complete System offering peri-operative professionals unprecedented convenience and safety for the "Just-In-Time" terminal sterilization of temperature tolerant surgical instrumentation and supplies.

ONE TRAY® allows for 'Just-in-Time' reprocessing of surgical instrumentation in response to unpredictable demand with the same reliable filtered-vent design used by standard rigid containers.

ONE TRAY® complies with both AORN and AAMI recommendations for the safe handling, transport and delivery of items terminally sterilized on a "Just-In-Time" basis.


   
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