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Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic 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 intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.

This submission is provided for modifications to the predicate device, which includes design changes and addition of an optional loose extended finger flange. Details are provided in Table 1 hereafter. The Safe'n'Sound® Staked Passive Delivery System - Plajex® Version is a non-sterile single use anti-needle stick accessory for use with Plajex® sterile prefilled ISO Standard plastic syringes. It fits with Plajex® 1 mL-long staked syringes with a maximum needle length of ½". It consists of a subassembly with a loose plunger rod and an optional loose extended finger flange. The proposed device will be assembled along with the prefilled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the body protecting the user from potential sharps needle stick injury. The device is made of molded plastic and have a stainless steel spring.