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510(k) Data Aggregation

    K Number
    K052567
    Device Name
    ONE TRAY SEALED STERILIZATION CONTAINER
    Manufacturer
    STERILE CONTAINMENT TECHNOLOGY, LLC.
    Date Cleared
    2006-03-13

    (175 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERILE CONTAINMENT TECHNOLOGY, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ONE TRAY® Sealed Sterilization Containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments or an instruments or an instrument set for immediate use following flash sterilization. This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm. After sterilization, ONE TRAY provides for the safe transport and assured delivery for immediate use of the enclosed devices in a sealed container with tamper evident security and load record documentation according to AAMI and AORN guidelines.
    Device Description
    ONE TRAY® is a sealed rigid container with a rectangular patterned group of perforations forming vented areas in the lid and base. Dispossable hydrophobic SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filters cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.
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