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510(k) Data Aggregation

    K Number
    K163578
    Device Name
    EasyTouch Safety Pen Needle
    Date Cleared
    2018-08-03

    (591 days)

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

    MHC Medical Products, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
    Device Description
    EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.
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