Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

The Easydrip pen needles are single-use, sterile, non-pyrogenic medical devices designed for subcutaneous injection of fluids and FDA-approved drugs using pen injector devices. Four models are included: Easydrip Classic, Easydrip Plus, Easydrip Classic Pro, and Easydrip Plus Pro, all comprising a stainless steel needle, needle hub, inner and outer caps, sealing paper, and silicone oil coating.

Key differences from the predicate include: broadened indications from insulin-only to general drugs; two new models (Classic Pro and Plus Pro) with 5-bevel needle design instead of 3-bevel; outer cap material changed to allow polypropylene in addition to polyethylene; and removal of 29G needles from Plus and Plus Pro models. All models maintain the same operation method, sterilization (irradiation, SAL 10⁻⁶), needle gauges (29G/30G/31G/32G/33G where applicable), and lengths (4–12.7mm).

ISO 9626 and ISO 11608-2 for performance requirements; ISO 10993 series for biocompatibility testing, including cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, and pyrogen testing. Bench testing included needle dimensions, stiffness, flow rate, hub-needle bond, assembly ease, needle removal torque, and particulate tests.