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510(k) Data Aggregation

    K Number
    K133632
    Device Name
    PERICAN ULTRA
    Manufacturer
    B.BRAUN MEDICAL, INC
    Date Cleared
    2014-06-27

    (213 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    B.BRAUN MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The B. Braun Perican Ultra needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.
    Device Description
    The B. Braun Perican Ultra needle is a single use, disposable anesthesia needle (18 Ga.) with Tuohy (curved) bevel. The needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter. The proposed needle is composed of a hollow stainless steel cannula with 1 cm depth markings along the length of the cannula. The cannula is also designed with small 'echogenic' etched markings intended to enhance visibility of the needle when using an ultrasound imaging device. The cannula are secured to the winged polycarbonate hub using an epoxy resin and plastic spacer. The Perican Ultra needle is provided with a plastic stylet, which is pre-assembled inside the needle cannula. The hub is designed with a Luer adapter to facilitate attachment of the needle to anesthetic administration devices, such as a syringe.
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