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510(k) Data Aggregation

    K Number
    K213800
    Device Name
    Artiglass NRFitTM Tip L.O.R. Glass Syringes
    Manufacturer
    Artiglass Srl
    Date Cleared
    2022-05-19

    (164 days)

    Product Code
    QEH, FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Artiglass Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Artiglass NRFit tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration.
    Device Description
    The Artiglass NRFit TM tip Glass Syringes provided not sterile with ISO 80369-6 (NRFit™) compliant fittings. They are available in 5mL and 10mL, lock and slip configurations and 5mL and 10mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a borosilicate neutral with a graduated scale in milliliters (mL), a borosilicate neutral glass plunger and a nickel-plated brass tip. The plunger rod is amber colored to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles.
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    K Number
    K122416
    Device Name
    ARTIGLASS L. O.R. GLASS SYRINGE
    Manufacturer
    ARTIGLASS SRL
    Date Cleared
    2013-05-03

    (268 days)

    Product Code
    FMF, ART
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTIGLASS SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Artiglass LOR Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
    Device Description
    Artiglass L.O.R. Glass Syringe is glass syringe similar to that of a standard piston syringe. It is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique. The Artiglass L.O.R. Glass Syringe is provided not sterile, in bulk form to other manufacturers as part of an epidural insertion trays as a component to the epidural kit. The syringe may be sterilized before use and it can be re-sterilized via Autoclave. Artiglass L.O.R. Glass Syringe is intended to be used only by qualified personnel. This syringe is not intended for injection or aspiration. The Artiglass L.O.R. Glass Syringe is available in volume of 5ml and 10 ml.
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