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    K Number
    K151061
    Device Name
    Cornea Cold
    Manufacturer
    EUROBIO
    Date Cleared
    2015-08-06

    (108 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROBIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hypothermic (2-8°C) human corneal storage for 14 days
    Device Description
    Cornea Cold® is a sterile hypothermic corneal storage medium intended for human corneal storage at 2-8°C, for up to 14 days. Corneas are directly placed in Cornea Cold storage medium after surgery, and stored in eye banks between +2°C for a maximum of 2 weeks. The shortest storage time is determined by the time needed to obtain serology results of the donor. It is for single use, to be used by physicians or highly skilled personnel such as bank operators. The device gets into direct contact with the patient by accumulation in the cornea graft.
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