UDI Size Types
UDI Size Types are a sub-category of the clinical size categories and are used to classify clinical sizes and attributes. Each size type is assigned a corresponding interface code to the FDA GUDID database and EU EUDAMED database.
The Size Types page is accessed using Tell Me. Choose the
icon, enter Size Types, and then choose the related link.
The fields are described in the following table.
| Field | Description |
|---|---|
| Code | Specifies a unique code for the UDI Size Type. |
| Description | Specifies a description for the UDI Size Type. |
| Category | Specifies the UDI size category the record belongs to. |
| FDA Code | Specifies the code that will be used for exports to GUDID. It must begin with "C", followed by digits. If no FDA code is defined, then the size type is not considered for export. |
| EU Code | Specifies the code that will be used for exporting clinical sizes to the EUDAMED database, but not for exporting storage and handling conditions. The code must begin with "CST", followed by digits. The default value for custom size types is CST999. If no EU code is defined, then the size type is not considered for exporting clinical sizes. |
The UDI Size Types are partly predefined value codes that are assigned to clinical sizes and also to storage and handling types. Users can add default codes, delete unused default codes, and add their own codes.
Tip
Use the predefined views to filter the page to Default or Custom codes.
With the setup of the concrete item attributes and their characteristics, the respective UDI Size Types are assigned accordingly.
Insert Default Codes
Choose the Insert Default Codes action to insert size type codes of different categories predefined by the app.
If there is already a code with an identical name, it will not be updated. This means that accidentally deleted default codes can be restored at any time with this function.
Note
Default size types can also be created by choosing Actions > Insert Default Codes on the Unique Device Identification Setup page. However, this function also adds UDI Symbol Codes, UDI Sterilization Methods, and UDI Measure Units.
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