Device description and product specification, including variants and accessories 2.1 The dossier should contain the following descriptive information for the device:— (a) A general description including its generic name, model name, model No., materials of construction, intended use, indications, 44[instructions for use or electronic instructions for use], contraindications, warnings, precautions and potential adverse effects; (b) the intended patient population and medical condition to be diagnosed or treated and other considerations such as patient selection criteria; (c) principle of operation or mode of action, accompanies by animation or videos (if available); (d) an explanation of any novel features; (e) a description of the accessories, other medical device and other product that are not medical device, which are intended to be used in combination with it and it should also be clarified whether these accessories or device are supplied as a system or separate components; (f) a description or complete list of the various configurations or variants of the device that will be made available; (g) a general description of the key functional elements, e.g. its parts or components (including software if appropriate), its formulation, its composition, its functionality and where appropriate, this will include:labeled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts or components, including sufficient explanation to understand the drawings and diagrams; (h) a description of the materials incorporated into key functional elements and those making either direct contact with a human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids. Complete chemical, biological and physical characterization of the material(s) of the medical device; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 107 of 248 (i) for medical devices intended to emit ionizing radiation, information on radiation source (e.g. radioisotopes) and the material used for shielding of unintended, stray or scattered radiation from patients, users and other persons shall be provided.