2.0 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;