Adding Clinically Relevant Size Details

You can add clinical measurement details corresponding to the medical device product to the device identification object. You can add multiple measurements of different types.

Before you begin: You must be on the Clinically Relevant Page.
See Also
Adding Storage Condition Details
  1. From the page toolbar, click Enable Edit.
  2. From the page toolbar, click Insert new row.
    An empty row appears.
  3. Enter the following details.
    Column Name Description
    Size Type Select a measurement type. You can select Circumference, Depth, Device Size Text specify, French Catheter Gauge, Greatest Diameter, Height, Length, Lumen Diameter, Needle Gauge, Second Greatest Diameter, Third Greatest Diameter, Total Volume, or Width.
    Value Type the measurement value.
    High Value Type the high value for the measurement condition type. This option is not considered in the submission of the DIs that are created in USA.
    UOM Select a unit of measure.
    Type Text Type any additional information or specific measurement conditions.
  4. Click Save.
    The details are saved.
  5. Click Disable Edit to exit edit mode.

The measurement details are added to the device identification object.