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The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

1 ml Sterile Hypodermic Syringe is 3-piece design. These 3 pieces are piston, plunger and barrel. The piston is made from isoprene rubber. Barrel is made from polypropylene. Plunger is made from polypropylene and polyethylene combination. Needle is made from stainless steel 304 grade and hub of needle is made from polypropylene. There are with or without needle configurations within this Special 510k submission. There are luer and luer-lock configurations within this special 510k submission. This special 510k submission only covers the 1ml syringe but several needle dimensions including 21Gx5/8", 23Gx1", and 25Gx1". The barrel marking scale interval is 0.1 ml and legible for all configurations covered by this Special 510k submission. Luer and Luer-lock have a 6% conical design. The barrel is transparent. The length (without needle), outside diameter are 99.30/100.2mm, 6.9/6.75 and 4.70/4.70, respectively for luer and luer-lock configurations. Intended users are medical professionals and trained caregivers. It is prescription use only. It is EtO sterile and a single use device. Packaging combination is maintained from a transparent sterilization film and Tyvek paper appropriate to EtO sterilization. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. The products covered in this special 510k are in compliance with ISO 10993-1 and ISO 7886-1.

The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The sterile insulin syringe for single use with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile insulin syringe for single use with the calibration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock consists of a Piston, Plunger, and Barrel. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in various lengths, diameters, tip types, needle tip configurations, nozzle types, barrel marking specs, volumes, sizes, and needle lengths. Materials include Isoprene Rubber, PP, PE, and SUS304. The Sterile Insulin Syringe for Single use, with needle consists of a Needle Cap, Needle, Piston, Plunger, Barrel, and End Cap. It is EO Sterilized and intended for Prescription use by patients. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in 0.3ml, 0.5ml, and 1ml volumes with fixed needles of 8mm and 13mm lengths. Materials include Isoprene Rubber, PP, PE, and SUS304. The Sterile Hypodermic needle for Single use consists of a Protective cap, Needle, Adhesives, and Needle hub. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and for Manual Use Only. It comes in various sizes and needle lengths. Materials include PP, Epoxy resin, and SUS304.