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Single use devices that are indicated for use as an accessory with pre-filled 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 needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Additionally, the PLUS device is designed with a larger viewing window indicated where pharma company offering is a low fill volume and instructions request visualization. The PLUS device is designed with a robust plunger and built in extended finger flanges indicated where pharma customer offering is viscous.

The modification to the predicate device is the addition of the X100L PLUS device to the UltraSafe Passive Needle Guard X-Series family. The SSI UltraSafe PLUS Passive Needle Guard is an antineedlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is non-sterile and single use. The activation of the UltraSafe PLUS Passive Needle Guard device remains the same. Upon completion of the guard will slide forward, cover and lock over the needle of the syringe. It is a visual and/or audible recognition that the device safety feature has activated. The SSI devices are categorized as skin contact with a duration of category A- limited (< 24 h) as per ISO 10993 Biological evaluation of medical devices- Part 1: Evaluation and testing.

Single use devices that are indicated for use as an accessory with pre-filled 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 needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

The SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is nonsterile and single use. The activation of the SSI UltraSafe Passive Needle Guard device remains the same. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe. It is a tactile and visual recognition that the device safety feature has activated. The modifications to the predicate device include additional plungers manufactured from Purell PolyOne X50109 polypropylene homopolymer, Ineos H20Z-00 polypropylene homopolymer or medical grade Delrin SC690 NC010. The SSI devices are categorized as skin contact with a duration of category A- limited (< 24 h) as per ISO 10993 Biological evaluation of medical devices- Part 1: Evaluation and testing.

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

The Safety Syringes UltraSafe Delivery System/Needle Guard devices are antineedlestick accessories for pre-filled ISO Standard glass syringes. ISO Standard glass syringes are supplied in multiple sizes. These devices are designed to fit syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL.

The UltraSafe Passive™, X-Series, Needle Guard is intended for use as a safety mechanism designed to reduce the occurrence of accidental needlesticks to healthcare professionals during disposal of a used syringe and needle assembly. The UltraSafe Passive, X-Series, Needle Guard is snapped onto the barrel of an ISO Standard pre-filled glass syringe, in a retracted position. Upon completing the injection, the UltraSafe Passive, X-Series, Needle Guard passively activates and covers the exposed needle. When the Passive Needle Guard is activated, it provides protection from an accidental needlestick. The healthcare professional disposes the used syringe and needle assembly in a sharps container. UltraSafe Passive™, X-Series, Needle Guards are single use devices that are indicated for use as an accessory with ISO Standard pre-filled glass syringes to protect healthcare professionals from accidental needle sticks.

The UltraSafe Passive™, X-Series, Needle Guard is an accessory for ISO Standard pre-filled glass syringes. ISO Standard pre-filled glass syringes are supplied in multiple sizes. They fit with ISO Standard pre-filled glass syringes ranging from 0.5 mL to 5.0 mL of fill volume. The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly and a reusable Syringe Plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges for injection of anesthetic solution for profound anesthesia of oral tissues. The Needle Guard sheath manually slides forward over the needle in between injections and after injection(s) have been completed. The Needle Guard helps protect dental healthcare professionals from accidental needlesticks. The intended patient population is unrestricted and includes children and adults of all ages.

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly to help prevent needlestick and a reusable Syringe Plunger assembly that is used to administer local anesthetic solutions.

The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit. The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.

The UltraSafe® Model C200 Injector with Needle Guard is a product which is intended to be used with a sterile medication cartridge with needle to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which consists of a safety guard that can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle. The guard requires a two-handed action in order to cover the needle point after use. The Model C200 Injector is made of K-Resin KR01, KR03, and ABS Resin.

The UltraSafe® Model T200 Injector with Needle Guard is designed to hold a TUBEX® Sterlie Cartridge-Needle Unit 2.5 ml. in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit. The UltraSafe® Model T200 Injector is used with a Tubex® Sterile Cartinge-Needle Unit 2.5 ml. to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for parenteral methods of administration.

The UltraSafe® Model T200 Injector with Needle Guard is a product which is intended to be used with a TUBEX® Sterile Cartridge-Needle Units 2.5 ml to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle.

Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and parenteral methods of administration.

The UltraSafe® Needle Guerd is an accessory to the ISO 11040-4 standard glass syringe that is pre-filled. The device is totally disposable. It is a safety guard that can be mated with a pre-filled syringe of the same size. After use of the syringe, the guard is activated covering the needle and thus protecting the caregiver by eliminating the need to recap the needle and minimizing accidental needle stick injuries during disposal of the syringe/needle.