Clinically Relevant Page

This page lists identifiers that provide the measurement information about the medical device product.

To access this page:

  1. From the Device Identification List page or the home page, click the required DI number.
  2. Select the Device Characteristics category.

This page discusses:

See Also
Device Characteristics Page
Storage Condition Page

Columns

Column Name Description
Size TypeMeasurement type. Possible values are Circumference, Depth, Device Size Text specify, French Catheter Gauge, Height, Length, Lumen Diameter, Needle Gauge, Total Volume, Width, Weight, Pressure, Pore Size, Area/Surface Area, Angle, Patient.
ValueValue of the measurement condition type.
High Value High value for the measurement condition type. This option is not considered in the submission of the DIs that are created in USA.
UOMUnit of measure.
Type TextAdditional information or any specific measurement conditions.

Actions

Action DescriptionFor More Information
Delete Deletes the measurement condition.
Note: The device identifier must be in the Draft or the Review state.
--
Insert new row Inserts a new measurement condition row in edit mode.Adding Clinically Relevant Size Details
> Insert AboveInserts a new row above the selected row.--
> Insert BelowInserts a new row below the selected row.--
Remove inserted row(s)Removes the selected newly inserted row.--
Enable Edit Activates edit mode in which you can insert rows and remove newly inserted rows. In edit mode, you can also modify all the fields. After you make the required changes, click Save to save the details and click Disable Edit to exit edit mode.--