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510(k) Data Aggregation

    K Number
    K023658
    Device Name
    STERILIZATION CASES AND TRAYS
    Manufacturer
    CARR METAL PRODUCTS, INC.
    Date Cleared
    2003-03-25

    (145 days)

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

    CARR METAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle. These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 °C for a 4-minute minimum plus a minimum of 15 minutes drying time.
    Device Description
    Sterilization cases, trays, and cassettes designed to hold various general dental, medical device instrumentation during the cleaning, use, and sterilization process. The design is a container (case) with separate lid, which has various methods of holding the instruments in place. These are trays and cassettes, which are made of metal and plastic. They are available in various sizes ranging from [width x length x height (depth)] 10.375 " x 21.75" x 21.75" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case.
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    K Number
    K972138
    Device Name
    CARR RIGID CONTAINER SYSTEM
    Manufacturer
    CARR METAL PRODUCTS, INC.
    Date Cleared
    1997-11-13

    (160 days)

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

    CARR METAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Prevacuum steam and EO sterilization. Sterility assurance tested up to 30 days.
    Device Description
    A rigid container system include a base available in several depth sizes ( 2.5", 3.0", 3.5", 4.0" and 5.0") and a lid which fits any of the bases. The lid is a standard size which fits any size (depth) of base, it also incorporates a filter retainer unit which holds a disposable filter, has a seal and incorporates a latching mechanism which latches the lid and base together.
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