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510(k) Data Aggregation

    K Number
    K151311
    Device Name
    Safe Block Pen Needle
    Manufacturer
    Artsana S.P.A
    Date Cleared
    2016-02-10

    (268 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Artsana S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle. The shield also serves to conceal the needle before and after injection.
    Device Description
    SAFETY PEN NEEDLE. Safe Block Pen Needle is designated for use with pen injector for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. Safe Block Pen Needle are offered in one gauge size (31G) and in a various lengths (5mm and 8mm). The Safe Block Pen Needle is sterile (ETO sterilization), non toxic and non-pyrogenic. It's a disposable single use device. Additionally the Safe Block Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. Prior to injection the user will attach the Safe Block Pen Needle to the pen. The shield of Safe Block Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The Safe Block Pen Needle should be removed from the pen and discarded.
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    K Number
    K052667
    Device Name
    ARTSANA PISTON AND INSULIN SYRINGES
    Manufacturer
    ARTSANA S.P.A.
    Date Cleared
    2005-11-25

    (59 days)

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

    ARTSANA S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Artsana disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
    Device Description
    Not Found
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    K Number
    K051783
    Device Name
    ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
    Manufacturer
    ARTSANA S.P.A.
    Date Cleared
    2005-10-04

    (95 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTSANA S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
    Device Description
    Not Found
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