Regulatory Compliance

FDA Clearance

The patented ONE TRAY® Sealed Container System is 510(k) cleared to sterilize a 25 pound gross weight load in a 4 minute pre-vacuum cycle at 270°. 

 

ONE TRAY® allows for reprocessing of medical devices in response to unpredictable demand with the same reliable filtered-vent design used by standard rigid containers.

 

ONE TRAY® is designed to meet both AORN and AAMI recommendations for the safe handling, storage, transport and aseptic delivery of sterilized contents.

 

ONE TRAY® meets the guidance  recommendations of AAMI and AORN.

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