Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K172751
    Device Name
    iVitri Straw
    Manufacturer
    Date Cleared
    2018-02-09

    (150 days)

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

    Reprobitech Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iVitri®Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
    Device Description
    The iVitri® Straw device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® Straw device consists of a square-shaped polystyrene stick and acrylonitrile butadiene styrene (ABS) cap. As part of the vitrification procedure, the embryos are loaded on the tip of the stick, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during handling procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
    Ask a Question

    Ask a specific question about this device

    K Number
    K162640
    Device Name
    iVitri EZ
    Manufacturer
    Date Cleared
    2017-06-30

    (281 days)

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

    REPROBITECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iVitri® EZ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
    Device Description
    The iVitri®EZ device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® EZ device is composed of a twopiece polystyrene assembly with a square-shaped stick (body) and cap. As part of the vitrification procedure, the embryos are loaded on the tip, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1