Completing the UDI Super Set Form
• For UDI templates, this is the New UDI Template or Edit UDI Template window.
• For UDI Super Set, this is the Edit UDI window.
Set Attributes
Complete the following fields in the FDA Attributes section in Set Attributes step.
 |
The system completes some information in advance.
• If you are editing a UDI Super Set, the system completes the Name and Number fields.
• If you created a UDI Super Set from a part, the system completes some fields with information from the part.
• If you created the UDI Super Set using a UDI Super Set template, the system completes some fields with information from the template.
|
1. Under Device Identifier Information, complete the following fields:
|
Attribute
|
Description
|
||
|---|---|---|---|
|
Device Identifier Issuing Agency
|
Select the name of the issuing agency of the device identifier:
• GS1–GTIN
• HIBCC
• ICCBBA
|
||
|
Device Identifier
|
Enter a primary device identifier number. This number is the primary lookup for a medical device product. It must meet the requirements to uniquely identify a device through its distribution and use.
The primary DI number is located on the base package, which is the lowest level of a medical device containing a full UDI.
|
||
|
Unit of Use Device Identifier
|
Enter a unit of use device identifier number. For example, a unit of use identifier would be assigned to an individual electrode when the electrode is distributed in a package of 10. This associates the use of a device with a patient.
|
||
|
Direct Part Marking Device Identifier
|
Enter a direct part marking device identifier, if the identifier is different from the primary device identifier. This identifier is marked directly on the medical device. This only applies to devices subject to direct marking requirements as described under 21 CFR 801.45.
|
2. Under Device Product Information, complete the following fields:
|
Attribute
|
Description
|
|---|---|
|
Labeler DUNS
|
Enter the DUNS number. This is the business number issued by Dun & Bradstreet (D&B) that matches the company name on the device label.
|
|
Brand Name
|
Enter the proprietary brand name of the medical device as used in product labeling or in the catalog. This information can appear in the following ways:
• On a label attached to a durable device
• On a package of a disposable device
• In labeling materials of an implantable device
|
|
Model Number
|
Enter the model number or version number found on the device label or accompanying packaging.
|
|
Catalog Number
|
Enter the catalog, reference, or product number found on the device label or accompanying packaging.
|
|
Device Description
|
Enter a detailed description of the device. Include additional relevant information about the device that is not already captured as a distinct GUDID data attribute.
|
3. Under Sterilization and Device Characteristics, complete the following fields:
|
Attribute
|
Description
|
|---|---|
|
Packaged Sterile
|
Select Yes if the medical device is free from viable microorganisms. If you select Yes, complete the Sterilization Method section in the Table Data step.
|
|
Requires Sterilization
|
Select Yes if the medical device requires sterilization before use. If you select Yes, complete the Sterilization Method section in the Table Data step.
|
|
Contains Latex
|
Select Yes if the medical device or packaging contains natural rubber that would come into contact with a person as described under 21 CFR 801.437.
Selecting Yes indicates that the device label or packaging contains one of the following statements:
• "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
• “This Product Contains Dry Natural Rubber."
• “Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
• "The Packaging of This Product Contains Dry Natural Rubber."
|
|
Labeled as ‘Not made with latex’
|
Select Yes if natural rubber latex was not used to manufacture the medical product or container. This only applies to devices that are not regulated by 21 CFR 801.437.
|
|
Contains Human Tissue
|
Select Yes if the device contains human tissue. This indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3.
|
|
Kit Product
|
Select Yes if the product is a kit. This indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products (including medical devices) that are packaged together to achieve a common intended use and are being distributed as a medical device.
|
|
Combination Product
|
Select Yes if the product is a combination product according to the FDA. This indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). At least one of the products in the combination product must be a device.
|
|
Single-Use
|
Select Yes if the product is a single-use (consumable or disposable) product.
|
|
MRI Safety Status
|
If the product has been tested for MRI safety, select the safety status of the MRI testing:
• MR Conditional
• MR Safe
• MR Unsafe
• Labeling does not contain MRI Safety Information
|
4. Under Production Identifiers, complete the following fields:
|
Attribute
|
Description
|
|---|---|
|
Lot Controlled
|
Select Yes to indicate that the device is managed by lot number. This number can be found on the label or packaging material. A lot or batch meets the following criteria:
• One or more components or finished devices that consist of a single type, model, class, size, composition, or software version
• Manufactured under essentially the same conditions
• Intended to have uniform characteristics and quality within specified limits
|
|
Serial Controlled
|
Select Yes to indicate that the device is managed by serial number. This number can be found on the device label or accompanying packaging. It is assigned by the company and should be specific to each device.
|
|
Manufacture Date Controlled
|
Select Yes to indicate that the device is managed by the date a specific device was manufactured.
|
|
Expiration Date Controlled
|
Select Yes to indicate that the device is managed by expiration date. This is the date by which the device label states that the device must or should be used.
|
|
By Donation Identification Number
|
Select Yes to indicate that the device is managed by donation identification number.
|
|
Device Count
|
Enter the number of medical devices in the base package. The base package is the package configuration as labeled with and identified by the primary device identifier. For example, if the base package is a box of 100 gloves, and the primary device identifier is 101, the device count is 100.
|
5. Under FDA Attributes, complete the following fields:
|
Attribute
|
Description
|
|---|---|
|
Device Identifier Record Publish Date
|
Select the date the device identifier record should be published in the public search module. Click the calendar icon  to select the completion date for the request. You can also enter the date manually using the YYYY-MM-DD format. |
|
Discontinued Date
|
Select the date the device was discontinued, if applicable. Click the calendar icon to select the completion date for the request. You can also enter the date manually using the YYYY-MM-DD format. |
|
Exempt from Direct Part Marking
|
Select Yes if the company can claim that the product is exempt from direct part marking requirements as described under 21 CFR 801.45.
|
|
Exempt from Premarket Authorization
|
Select Yes to indicate that the device is exempt from FDA premarket regulations.
|
|
Prescription Use
|
Select Yes if the product requires a prescription.
|
|
Over the Counter Use
|
Select Yes if the product can be used over the counter.
|
|
Version
|
The current version of the UDI/FDA object.
|
6. Click Next.
Table Data
There are two tables under the Table Data step:
• UDI Details
• Packaging Configuration
UDI Details
To add the UDI Details, refer to the sections below.
UDI Secondary Device Identifier
To add the UDI secondary device identifier details, do the following:
1. Click the add detail icon 
.
.2. From the Select a Type drop-down, select UDI Secondary Device Identifier.
3. Click the edit table data icon 
.
.The Edit Details wizard is displayed.
4. From the Issuing Agency list, select the name of the issuing agency.
5. In the Secondary Device Identifier field, type a secondary device identifier number. This is an alternate lookup for a medical device product. The identifier is issued from a different issuing agency than the primary device identifier.
6. Click OK.
UDI Contact
To add the UDI contact details, do the following:
1. Click the add detail icon .
.2. from the Select a Type drop-down, select UDI Contact.
3. Click the edit table data icon .
.The Edit Details wizard is displayed.
4. In the Phone Number field, type the phone number of the contact.
5. In the Phone Extension field, type the phone extension number.
6. In the Email Address field, type the email address.
7. Click OK.
| | Regulatory contacts are for internal use only; this is a person whom the FDA can contact. Support contacts are consumer or provider contacts for public use. It is recommended that you use templates to populate device contact information when creating UDIs. |
UDI GMDN and FDA Term Code
To add the UDI GMDN and FDA term code details, do the following:
1. Click the add detail icon .
.2. From the Select a Type drop-down, select UDI GMDN and FDA term Code.
3. Click the edit table data icon .
.The Edit Details wizard is displayed.
4. In the GMDN and FDA Term Code field, type the GMDN and FDA code. The GMDN and FDA codes are a defined set of codes managed by the GMDN Agency.
5. Click OK.
Sterilization Method
To add the sterilization method details, do the following:
1. Click the add detail icon .
.2. From the Select a Type drop-down, select Sterilization Method.
3. Click the edit table data icon .
.The Edit Details wizard is displayed.
4. From the Sterilization Method drop-down, select the sterilization method.
5. Click OK to add them to the table.
UDI Size Device Characteristics
To add the UDI size device characteristics, do the following:
1. Click the add detail icon .
.2. From the Select a Type drop-down, select UDI Size Device Characteristic.
3. Click the edit table data icon .
.The Edit Details wizard is displayed.
4. Select a size type.
5. Select a unit of measure.
6. Enter a value.
7. Enter a description.
8. Click OK to add them to the table.
UDI Storage Device Characteristics
To add the UDI storage device characteristics, do the following:
1. Click the add detail icon .
.2. From the Select a Type drop-down, select UDI Size Device Characteristic.
3. Click the edit table data icon .
.The Edit Details wizard is displayed.
4. From the Storage Type drop-down, select a storage type. This indicates the storage requirements for the device, such as temperature or humidity.
5. From the Unit of Measure drop-down, select a unit of measure.
6. In the Low Value field, enter a low value for storage requirements, such as temperature, humidity, and so on.
7. In the High Value field, enter a high value for storage requirements, such as temperature, humidity, and so on.
8. In the Description field, enter a description.
9. Click OK to add them to the table.
UDA Super Set
To add UDA Super Set detail, do the following:
1. Click the add detail icon . From the Select a Type drop-down, select one of the following:
. From the Select a Type drop-down, select one of the following:◦ FDA Listing Number
◦ FDA Premarket Authorization Number
◦ FDA Product Code
2. Click the edit table data icon . The Edit Details wizard is displayed.
. The Edit Details wizard is displayed.3. Edit all the related details.
4. Click OK.
Packaging Configuration
To add the packaging information, Under Packaging Configuration, do the following:
| | This option is available for creating and editing UDI submissions and for editing UDI templates, but not for creating UDI templates. |
• To expand the hierarchy, click the expand icon 
.
.• To collapse the hierarchy, click the collapse icon 
.
.• To create UDI packaging, click the new UDI packaging icon 
. In the Create UDI Packaging window, do the following:
. In the Create UDI Packaging window, do the following:1. In the Description field, enter a text description.
2. In the Package Device Identifier field, enter a device identifier for the package configuration that contains multiple units of the base package (not including shipping containers).
▪ This identifier must be unique.
▪ This identifier does not include shipping packages.
▪ For example, if there are 10 glove boxes in a carton, the package device identifier is the UDI on the carton (such as 301). If there are 10 glove boxes in a carton and 5 cartons in a case, the package device identifier is the UDI on the case (such as 201). If there are 5 cartons in a pallet, the package device identifier is the UDI on the pallet (such as 401). The pallet contains 5 cartons with 10 glove boxes in a carton.
3. In the Quantity field, enter the number of packages with a unique primary device identifier within a packaging configuration.
For example, if a package configuration case contains 4 boxes of the base package, the quantity per package is 4. If a package configuration carton contains 10 boxes of the base package, the quantity per package is 10. If a package configuration pallet contains 5 cartons of the base package, the quantity per package is 5.
4. In the Create UDI Packaging window, click Finish.
When you complete all information in the Table Data section, click Finish.
UDI Super Set are validated against published rules before moving to the next state. Templates are not validated against published rules.