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510(k) Data Aggregation

    K Number
    K090429
    Device Name
    NUNC IVF CENTERWELL AND ICSI DISHES
    Manufacturer
    THERMO FISHER SCIENTIFIC (NALGE NUNC INTL)
    Date Cleared
    2009-09-18

    (211 days)

    Product Code
    MQK, MOK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO FISHER SCIENTIFIC (NALGE NUNC INTL)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IVF ICSI dish is intended for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
    Device Description
    The IVF ICSI Dish is an injection molded polystyrene dish with a single dish-sized well. The dish has overall outside dimensions of 1.999" (50.77 mm) diameter and 0.340" (8.64 mm) height without the lid. Addition of the lid increases overall height to 0.384" (9.75 mm). The dish has a fluid capacity of 12.5 ml, if filled to the top of the sidewall; however, individual IVF clinics typically use a small fraction of that potential volume. The polystyrene used for the dish and lid are virgin crystal-grade polystyrene, which has successfully passed the USP 32 <88> Class VI test for in vivo cytotoxicity and USP 32 <87> for in vitro cytotoxicity. The dish is designed in such a way that when the lid is mounted on the dish, dishes can be stacked. The lid can be removed with one hand. The IVF ICSI Dish is packed in strips of 3 dishes with lids and 40 strips in a box for a total of 120 units. The IVF ICSI Dish is terminally sterilized by gamma irradiation to achieve an SAL of 10 °. The dish is non-pyrogenic as tested by LAL, and non-embryo toxic as tested by one-cell mouse embryo assay (MEA), The IVF ICSI dish is disposable and intended and labeled for single use.
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