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510(k) Data Aggregation

    K Number
    K041096
    Device Name
    WAGNER STERISET STERILIZATION CONTAINER
    Manufacturer
    Date Cleared
    2005-06-03

    (402 days)

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

    WAGNER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SteriSet Sterilizatoin Conatiner is intended to be used to ecnlose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility until used. The SterieSet Containers are designed for use with high-vacuum or pulse-vacuum steam sterilization systems. They are not suitable for gravity, gravity flash, or ethylene oxide (EO) gas cycles due to their "closed design".
    Device Description
    The containers are used for holding operating room instruments and/or textiles during vacuum-steam sterilization procedures and for maintaining sterility during storage and transport under proper hospital conditions.
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