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510(k) Data Aggregation

    K Number
    K201213
    Device Name
    Pasteur Pipette 3mL, Pasteur Pipette 1mL
    Manufacturer
    Date Cleared
    2020-12-16

    (225 days)

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

    HertART Aps

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.
    Device Description
    The Pasteur Pipettes are radiation-sterilized, single use, transparent low-density polyethylene pipettes intended for handling and transferring of liquids, media and gametes during assisted reproductive technology (ART) procedures. The pipettes are provided in two sizes, 1 mL (Model 16201) and 3 mL (Model 16202). Each pipette includes an integrated bulb end that is used to aspirate and expel liquid, media and gamete to and from the device. The pipettes also include a molded volume scale along the body of the pipette. The volume scale only provides an estimate of the aspirated volume. The pipettes will not come in contact with the human body during use.
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    K Number
    K150756
    Device Name
    Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
    Manufacturer
    Date Cleared
    2015-07-20

    (119 days)

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

    HERTART

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture
    Device Description
    The Micro well group culture dishes are injection molded and disposable. The dishes are round and supplied with a lid. The dishes holds 9 small wells respectively 16 small wells. The polymers used for the dishes are virgin crystal grade polystyrene, which has successfully passed 1- cell embryotoxicity test. The dishes are packed 1 unit in a sleeve, 10 sleeves in a case. The dishes are terminally sterilized by irradiation to achieve a SAL of 10-6. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by one cell Mouse Embryo Assay (MEA). The Dishes are single use devices.
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    K Number
    K123641
    Device Name
    CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
    Manufacturer
    Date Cleared
    2013-07-03

    (219 days)

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

    HERTART

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vitrolife Culture Dish 60 mm, Vitrolife Culture Dish 40 mm and Vitrolife Centre Well Dish are intended for IVF, suitable 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 Vitrolife 5 Well Culture Dish is intended for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques. The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI). The Vitrolife Micro Droplet Culture Dish is intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture.
    Device Description
    The HertART disposable dishes are injection molded. The dishes are supplied with a lid. The polymers used for the dishes are virgin crystal grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity, as well as 1-cell embryotoxicity test. The HertART dishes are packed in sleeves of x units in a box for a total of y units, as defined below: Vitrolife Culture Dish 60 mm: Round dish with lid: ø63 x 15,15 mm One round well 60 mm in diameter Well Volume: 24,00 mL Vitrolife Culture Dish 40 mm: Square dish with lid; 65,96 mm x 65,96 mm x 13,20 mm One round well: 40 mm in diameter, Well volume of 12,56 mL Vitrolife 5-well Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x. 13,20 mm 5 round wells, Well Volume: 1,7 mL Vitrolife Centre Well Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 1 well, round bottom, oval opening. Vitrolife ICSI Dish: Square dish with lid: 65,96 mm x 65,96 mm x 11,70 mm 1 square well with rounded corners Vitrolife Micro-droplet Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 12 round wells holds drops up to 50 µL Well Volume: 12.5 µL The dishes are terminally sterilized by gamma irradiation to achieve a SAL of 10 °. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by 1-cell Mouse Embryo Assay (MEA). The dishes are disposable and intended for single use.
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