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    K Number
    K251320
    Device Name
    XTRA4
    Manufacturer
    AL.CHI.MI.A. S.r.l
    Date Cleared
    2025-09-11

    (135 days)

    Product Code
    LYX
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K221759,K924165
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K221759

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    XTRA4 is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).

    Device Description

    XTRA4 (ref. EXT4 001-01) is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8°C for up to 14 days. It is designed as a single use 20 mL solution in glass vials. XTRA4 is intended to be used only by physicians or highly skilled personnel such as eye bank operators. The preservation of donor cornea is traditionally performed by storing them at temperatures between 2°C and 8°C in a storage medium containing deswelling agent(s).

    AI/ML Overview

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