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Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).
The product was cleared for sale by the U.S. Food and Drug Administration as a Class II medical device for the treatment of dentinal hypersensitivity, [13] and has been classified as an ‘effective, efficient, equitable and safe caries-preventative agent’ by the Institute of Medicine and the Millennium Goals of the World Health Organization ...
Medical halogen penlight: to see into the eye, natural orifices, etc. and to test for pupillary light reflex, etc. Medical ultrasound: to create an image of internal body structures Nasogastric tube: for nasogastric suction or the introduction of food or drugs into the body Nebulizer: to produce aerosols of drugs to be administered by ...
Class II. Class II are devices with moderate risk. [5] Class I and Class II devices are subject to less stringent regulatory processes than Class III devices. [5] Class I or II devices are focused on registration, manufacturing, and labeling. [5] In general they do not require clinical data. [5] Most class II devices go through a PMN (a 510[k ...
cite journal}}: CS1 maint: multiple names: authors list : Auvard's speculum: Alfred Auvard: Gynaecology: vaginal speculum [4] Luer taper, Luer lock: Hermann Wülfing Luer: General use: Fitting to ensure leak-free connection in medical fluid administration systems [5] Penrose drain: Charles Bingham Penrose: Surgery
Medical devices (7 C, 108 P) Diabetes-related supplies and medical equipment (22 P) Medical dressings (19 P) E. Emergency medical equipment (23 P) Endoscopes (4 P) I.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...