medical device

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medical device

Any article or health care product intended for use in the diagnosis of disease or other condition or for use in the care, treatment, or prevention of disease that does not achieve any of its primary intended purposes by chemical action or by being metabolized Examples Diagnostic test kits, crutches, electrodes, pacemakers, catheters, intraocular lens. See Class I, II, III devices, Significant risk device, Silicone implant. Cf Nonsignificant risk.

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Medical Dictionary

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