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    K Number
    K142022
    Device Name
    MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
    Manufacturer
    MEDLINE RENEWAL
    Date Cleared
    2014-12-19

    (147 days)

    Product Code
    NLY
    Regulation Number
    874.4140
    Why did this record match?
    Product Code :

    NLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.
    Device Description
    Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are sterile single use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. The Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally manufactured by OLYMPUS/Gyrus ACMI.
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