(ii) The device identifier portion of the UDI that appears as a permanent marking on the device;
(4) The proprietary, trade, or brand name of the device as it appears on the label of the device;
(5) Any version or model number or similar reference that appears on the label of the device;
(6) If the device is labeled as sterile, a statement to that effect;
(7) If the device is labeled as containing natural rubber latex that contacts humans, or is labeled as having packaging containing natural rubber latex that contacts humans, as described by SUBSEC 801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a statement to that effect;
(8) Whether a patient may be safely exposed to magnetic resonance imaging, nuclear magnetic resonance imaging, or magnetic resonance tomography while using the device, or while the device is implanted in patient.
(9) If the device is available in more than one size, the size of the particular version or model, together with the unit of measure, as it appears on the label of the device;
(10) The type of production identifiers that appear on the label of the device;
(13) The Global Medical Device Nomenclature (GMDN) term or code for the device;
(14) The total number of individual devices contained in the device package.
(a) Designation of contact for device identification. Each labeler must designate an individual to serve as the point of contact with
(b) Information shall be submitted via electronic means. All information required by this subpart shall be submitted electronically to
(c) Waiver from electronic submission. (1) A labeler may request a waiver from electronic submission of UDI data by submitting a letter addressed to the appropriate Center Director explaining why electronic submission is not technologically feasible; send the request by email to: email@example.com, or by correspondence to: UDI Regulatory Policy Support,
(2) If the establishment where the labeler is located has obtained a waiver from electronic submission of registration and listing information under section 510(p) of the Federal Food, Drug, and Cosmetic Act, the labeler is deemed to have a waiver from electronic submission of UDI data.
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