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510(k) Data Aggregation
(194 days)
The pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.
Easydrip Pen Needles are single-use, sterile, and non-pyrogenic medical device designed to be used with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. The subject devices include four models, i.e. Easydrip Classic, Easydrip Classic Pro, Easydrip Plus, and Easydrip Plus Pro. All models have the same operation methods and similar materials. The device comprises a stainless needle, needle hub, inner cap, outer cap and sealing paper, and the needle surface coated with silicone oil. The needle hub of the device can be screwed onto compatible pen injector devices.
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