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The Stat Medical Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin. This is the same intended use as previously cleared for the Stat Medical Pen Needle, K042917.

The Stat Medical Pen needle consists of 4 parts, the needle hub, the needle protector and the outer cover. The cannula is manufactured from 304 stainless steel. The cannula is produced into three sizes for the device (the 29g 12.7 mm (1/2 in), 31g 5mm (3/16 in) and the 31g 8mm (5/16 in). The cannula length and inner diameter are a constant for these three sizes, which differ in the outer diameter of the cannula. The hub is molded from medical grade polypropylene, and medical grade silicon. The needle is glued into place in the hub and is coated with a medical grade silicon/lube. The silicone oil/lube is non-toxic, pyrogen free, and free from contamination. After assembly, the hub and needle assembly are tested, packaged, and sterilized. The Stat Pen Needle is provided sterile via EO sterilization and is for Single Use only. The modification to the original filing is the correction of where the silicon coating is applied to the device, and a change in the product labeling to include the identification of the silicon coating. Product labeling may be found in section 9 of this submission.