Do you know how many data fields per product must be entered
into the FDA's GUDID?

gudid_data_elements-025775-editedMedical device manufacturers weighing whether to manually enter UDI information into the FDA GUDID can view an interactive chart detailing which data entry fields are required for each product submission.

  • Product ID Elements (Pri DI, Sec DI, UoU DI, DPM DI, GMDN)
  • Regulatory Elements (FDA Listing #, Auth. #, ProCode)
  • Labeler and Contacts
  • Characteristics (Sterile, Size, Production Control)
  • Package Elements(Pkg DI, Qty)

Submit the following information to access the interactive chart: