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Single use device that is indicated for use as an accessory with sterile 1 mL-long staked needle prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needle sticks. The devices can be used on a wide range of patients including children and adults.

This submission is provided for modifications to the predicate device, which includes design changes and a plunger rod raw material change. For details, please refer to Attachment 1 for Design Modifications Rationale. The Safe'n'Sound® Staked Passive Delivery System – Cone Version is a single use anti-needle stick accessory for use with sterile 1 mL-long staked needle prefilled ISO Standard glass syringes. It fits with 1 mL-long staked syringes with a maximum needle length of 1/2" and consists of a subassembly (body, cone, sleeve, and spring) and a loose plunger rod.