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510(k) Data Aggregation

    K Number
    K993535
    Device Name
    METAPAK MULTI-PURPOSE INSTRUMENT TRAY
    Manufacturer
    RILEY MEDICAL, INC.
    Date Cleared
    2001-12-07

    (780 days)

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

    RILEY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Riley Medical MetaPak Multi-Purpose Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. The Riley Medical MetaPak Multi-Purpose Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.
    Device Description
    The Riley Medical MetaPak Multi-Purpose Instrument Tray (MetaPak Instrument Tray) is an instrument container consisting of a rectangular box base with a cover that fastens to the base using latches on the short ends. The following sizes of bases and lids are available: - Tall hase and lid: 22" x 10" x 6" . - Short base and lid: 22" x 10" x 4" . - Extra long base and lid: 26" x 10" x 6" . Insert trays can be stacked in the container base to increase the instrument-carrying capacity of the container. The following insert sizes are available: - . Full insert: 21" x 9.5" x 2.5" - Small insert: 10" x 9.5" x 2.5" t Protective mats are available that can be placed on the insert trays and in the bottom of the container base to stabilize and protect the instruments. Slotted instrument bars and holders are also available to organize, stabilize, and protect the instruments in the container. The MetaPak Instrument Tray is identical to the predicate MultiPak Instrument Tray, cleared for marketing as K944025, with the exception of a modification to the materials for the container base. The original MultiPak Instrument Tray container base was constructed entirely of Radel plastic. The MetaPak Instrument Tray container base will be offered in aluminum, stainless steel, and an aluminum/Radel combination with the long sides made of aluminum and short sides made of Radel plastic.
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