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510(k) Data Aggregation

    K Number
    K112332
    Device Name
    FINE JECT INSULIN PEN NEEDLE
    Manufacturer
    TWOBIENS CO., LTD.
    Date Cleared
    2012-01-10

    (151 days)

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

    TWOBIENS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These disposable sterile Insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
    Device Description
    Fine Ject insulin pen needle consists of a Sterile Cap, needle hub, which can be fixed with needle and blister paper. The sterile cap has function to sustain sterilization of needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The needle cap covers intended to provide physical protection to the needle tube. Fine Ject insulin pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in variougauge sizes (29G, 30 G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). Fine Ject insulin pen needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge.
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