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510(k) Data Aggregation

    K Number
    K991249
    Device Name
    FALCON IVF FOUR WELL PLATE
    Manufacturer
    BECTON DICKINSON LABWARE
    Date Cleared
    1999-05-05

    (22 days)

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

    BECTON DICKINSON LABWARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FALCON® IVF Four Well Plate is sterile, nonpyrogenic, embryotoxicity tested, singleuse plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.
    Device Description
    The FALCON® IVF Four Well Plate is sterile (SAL of 10%), non-pyrogenic by Limulus Amebocyte Lysate (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic plate has four wells, each well area is 1.39 cm2 and each well volume is 1.8 mL. The plate has a unique lid which provides access to two wells at a time, while two remain covered. The wells are numbered and a large writing patch allows clear sample identification. Plates are packaged in individual peel-open trays for sterile presentation and are shipped in cases of 100 plates per case. The plates have perfectly flat, optically clear surfaces for optimum manipulation and observation of the ova and embryos. The lids are designed for aseptic manipulation and consistent venting to maintain proper humidification. The plates are manufactured from virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity. and the surfaces are treated to provide a more wetable or hydrophilic surface for tissue culture.
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    K Number
    K991251
    Device Name
    FALCON IVF ONE WELL DISH
    Manufacturer
    BECTON DICKINSON LABWARE
    Date Cleared
    1999-05-05

    (22 days)

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

    BECTON DICKINSON LABWARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures. The FALCON® IVF One Well Dish is sterile, nonpyrogenic, embryotoxicity tested, singleuse plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.
    Device Description
    The FALCON® IVF One Well Dish is sterile (SAL of 10-9, non-pyrogenic by Limulus Amebocyte Lysate (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic dish diameter is 60-mm, the well area is 2.45 cm2, the well volume is 2.5 mL, and the total volume is 20 mL. The dish is sold in units of 20 dishes per bag, and 500 dishes per case. The dishes have perfectly flat, optically clear surfaces for optimum manipulation and observation of the ova and embryos. The lids are designed for aseptic manipulation and consistent venting to maintain proper humidification. The dishes are manufactured from virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity. and the surfaces are treated to provide a more wetable or hydrophilic surface for tissue culture.
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    K Number
    K991253
    Device Name
    FALCON IVF ROUND DISH
    Manufacturer
    BECTON DICKINSON LABWARE
    Date Cleared
    1999-05-05

    (22 days)

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

    BECTON DICKINSON LABWARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures. The FALCON® IVF Round Dish is sterile, nonpyrogenic, embryotoxicity tested, single-use plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.
    Device Description
    The FALCON® IVF Round Dish is sterile (SAL of 10.9), non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic dishes have a diameter of 60-mm, well area of 24.07 cm², and well volume of 23.0 mL. The dish is sold in units of 20 dishes per bag, and 500 dishes per case. The dishes have perfectly flat, optically clear surfaces for optimum manipulation and observation of the ova and embryos. The lids are designed for aseptic manipulation and consistent venting to maintain proper humidification. The dishes are manufactured from virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity. and the surfaces are treated to provide a more wetable or hydrophilic surface for tissue culture.
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