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510(k) Data Aggregation

    K Number
    K070047
    Device Name
    NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
    Manufacturer
    NUNC A/S
    Date Cleared
    2007-05-18

    (134 days)

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

    NUNC A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nunc IVF 4-Well Dishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro ferilization techniques and cell culture. Nunc IVF PetriDishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro fertilization techniques and cell culture.
    Device Description
    The Nunc IVF PetriDishes and the Nunc IVF 4-well Dish are injection molded polystyrene dishes with either a single well or 4 wells and a polystyrene lid. The single well dishes are available in diameters of 35, 60 and 90 mm. Both single well and 4-well configurations are made with a clear polystyrene lid. The polystyrene used for the dishes and lids is a virgin crystal-grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity. The polystyrene is identical with the same Polystyrene use in the predicate device. For the 4-well configuration, the interface between the dish and the lid is designed with one cut off corner, hence the lid cannot be turned, and therefore cross contamination can be minimized. 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, which eases the use of the plate. The Nunc IVF tissue culture dishes are terminally sterilized by gamma irradiation to achieve SAL of 10-6. The dishes are non-pyrogenic as tested by LAL, and nonembryotoxic as tested by one cell mouse embryo assay (MEA). The Nunc IVF tissue culture dishes are disposable and intended for single use.
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    K Number
    K040717
    Device Name
    NUNC IVF MULTIDISH 4 WELLS NUNCLON
    Manufacturer
    NUNC A/S
    Date Cleared
    2004-08-12

    (146 days)

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

    NUNC A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse plasticware intended for preparing, manipulating or transferring gametes and embryos in group of the many of the in vitro fertilization techniques, and cell culture
    Device Description
    Not Found
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