GUDID size data: prepare numeric values, units and multiple dimensions
The acquired FDA table describes separate clinically relevant size types, numeric values and units, with conditions for a device available in more than one size. It accepts decimal values rather than fractions and gives separate entries for different dimensions. Prepare a normalized dimension table rather than one free-text “8 × 2 cm” value.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Observed FDA field relationships
Which fields change this workflow?
FDA Data Elements Reference Table; acquired link labelled December 17, 2024. Entry conditions and edit rules below are transcribed from that version.
Dimension type for the clinically relevant measurement of the medical device.
Recorded entry notes and format
Choose a value from the drop down LOV.
If you do not see your size type in the List of Values (LOV), then submit your suggestion for review as a new LOV via FDA UDI Help Desk. Submit with a subject line List of Values. Include the GMDN term(s) that the LOV is pertinent to.
If the desired Size Type is not in the current list, select 'Size Text, specify' and the data element 'Size Type Text' will appear (see below). It is expected that the 'Size Text, specify' will only be available for a limited time. Use this option to help us build a list of values that are appropriate for your device type. GUDID reserves the right to review all suggestions before adding values to the Size Type LOV.
More than one Size Value per Type and more than one Size Type may be added to each DI record.
Entry Example - 8cm by 2 cm - requires 2 entries
Entry 1 - Size Type = Length,
Size Value = 8, Size Unit of Measure = Centimeter
Entry 2 - Size Type = Width,
Size Value = 2, Size Unit of Measure = Centimeter
Numeric value for the clinically relevant size measurement of the medical device.
Recorded entry notes and format
Enter numeric value for size.
Decimals are accepted; fractions are not accepted. Each Size Value should be entered separately. GUDID is not accepting Size Value as a range at this time.
Entry Example - 8cm by 2 cm - requires 2 entries
Entry 1 - Size Type = Length,
Size Value = 8, Size Unit of Measure = Centimeter
Entry 2 - Size Type = Width,
Size Value = 2, Size Unit of Measure = Centimeter
The unit of measure associated with each clinically relevant size.
Recorded entry notes and format
Choose a value from the drop down.
Entry Example - 8cm by 2 cm - requires 2 entries
Entry 1 - Size Type = Length,
Size Value = 8, Size Unit of Measure = Centimeter
Entry 2 - Size Type = Width,
Size Value = 2, Size Unit of Measure = Centimeter
Additional undefined device size not represented in the GUDID Size Type LOV.
Recorded entry notes and format
Enter Size Type, Size Unit and Unit of Measure for each entry.
Data type: Type: Alphanum.
Length: 200
Entry values: NA
Reference limits and edit-rule footnotes
Add = Addition of new data is allowed; Delete = Deletion of entered data is allowed; Edit = Editing of entered data is allowed; None = NO edit, add, or delete are allowed; NA = data element is not able to be changed directly; most are ‘auto-populated’ fields whose information depends on another data element
Note: The above do not apply if the device is “unlocked” for editing. For more information on “unlocking” device records for editing, please visit www.fda.gov/udi [5]
See 21 CFR 830.310 and 830.340 for required data elements. [6]
Most of the information presented here is applicable to GUDID HL7 SPL submissions, but there are some differences pertinent to each submission option. Please refer to the HL7 SPL Implementation package of files for additional details on HL7 SPL xml file submission option. [7]
These are dated FDA reference-table fields, not an automated legal applicability assessment or validated submission. The AccessGUDID download schema is different from the FDA HL7 SPL submission implementation package. No quarantined schema is used.
A mapping worksheet for this workflow
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Identify clinically relevant dimensions
Confirm the controlled measurements and size variants; distinguish relevant dimensions from a marketing package description.
Useful evidence: Dimensioned specification and size-variant rationale.
Split values from units
Create one type/value/unit entry per dimension and review the recorded list-of-values and free-text conditions.
Useful evidence: Normalized size table, controlled units and exact source values.
Check conversion and precision
Record any justified unit conversion and precision separately; check decimals and unsupported ranges against the reference.
Useful evidence: Reviewed mapping rules, conversion calculations and exception report.
Work packages and dependencies
Conditional: GUDID size data: prepare numeric values, units and multiple dimensions — Review the controlled source evidence, prepare the field/relationship mapping described here, resolve exceptions and reconcile the intended records before confirming submission scope.
Questions for providers
How will you map multiple dimensions without flattening them into one string?
How do you preserve units and precision when converting source data?
How are missing size types or unsupported ranges escalated?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
