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Jia Chen Acupuncture Needle will be used for "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

The Jia Chen Acupuncture Needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture as determined by the States. The device consists of a solid stainless steel needle with handle attached to the needle to facilitate the delivery of acupuncture treatment. The material for Jia Chen Acupuncture needles is Austenitic stainless steel wire of ASMTF 899-94, type 304. The needle body is vacuum melted high purity stainless steel, with a good body tensile and spring, and the body surface finish has no visible defects under 100X magnifications. Jia Chen Acupuncture needle handles come in many different materials including copper, silver, plastic, steel tube and all stainless steel. The needle to handle bond strength is of at least 1 kilogram. The each single acupuncture needle is packed in plastic guide (insertion) tube. Jia Chen Acupuncture needles are sterilized with Ethylene Oxide GB 13098-98 and device sterility level (SAL) is at least 106. The ethylene oxide residue level in finished devices does not exceed EtO 25 ppm, Ethylene glycol 250 ppm, and ethylene chlorohydrin 25 ppm. Jia Chen Acupuncture needles are sterile, and for single use only.