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510(k) Data Aggregation

    K Number
    K233578
    Device Name
    BAHADIR STERILIZATION CONTAINERS
    Manufacturer
    Date Cleared
    2024-03-22

    (136 days)

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

    Bahadir USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterlity during storage and transport under proper hospital conditions. This container system is compatible for use with the following low temperature sterilizers and the cycles identified below: *STERIS V-PRO maX/maX2 - Lumen, Non-Lumen and Flexible Cycles *STERIS V-PRO s2/60 - Lumen, Non-Lumen and Flexible Cycles *STERRAD 100NX - Duo, Express, Standard and Flex Cycles *STERRAD NX - Standard and Advanced Cycles
    Device Description
    The Bahadir Sterilization Containers are a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS VPRO maX/maX2: Lumen, Non Lumen, Flexible - STERIS VPRO s2/60: Lumen, Non Lumen, Flexible ● - STERRAD NX: Standard, Advanced ● - . STERRAD 100NX: Standard, Express, Flex, Duo
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