Modifying Device Identification Details

You can modify the details of device identification objects and update the required fields. You can modify the details such as issuing agency, country, device class, DI number, and distribution status.

This task shows you how to:

Before you begin:
  • The device identification object must be in the Draft state or the Review state.
  • You must be the owner of the device identification object, a Product Manager, or a Regulatory Lead.
See Also
Modifying Device Status Details
Modifying Device Characteristics Details

Modify Device Identification Details

You can modify the details of device identification objects. You can update the details such as issuing agency, DI number, country, and device class.

Before you begin: You must be on the Device Identification List page.
  1. From the page toolbar, click Enable Edit.
  2. Update the following details for the required device identification objects.
    Column Name Description
    Issuing Agency Select the organization that issued the DI. You can select GS1, HIBCC, or ICCBBA.
    Primary DI Number Type the primary DI number. Ensure to follow the convention defined by the selected issuing agency.
    • For GS1, type a 14-digit number.
    • For HIBCC, type at least 6 characters comprising of numbers and alphabets. You can type up to 23 characters.
    • For ICCBBA, type 10 or 16 characters comprising of numbers and alphabets.
    Country Select the country in which the product is distributed commercially.
    Class Select the risk classification of the medical device. Device class varies with country.
    Device Description Type any additional information about the medical device.
    Note: The fields Issuing Agency, DI Number, Country, and Class are mandatory.
  3. Click Save.
    The updated details are saved.
  4. Click Disable Edit to exit edit mode.

Modify Device Information Details

You can modify the details of the selected device identification object. You can update the details such as issuing agency, DI number, country, device count, commercial distribution details, and direct marking details.

Before you begin: You must be on the Information Page.
  1. From the page toolbar, click Edit.
  2. Update the following details.
    Field Name Description
    Country Select the country in which the product is distributed commercially.
    Device Class Select the risk classification of the medical device. Device class varies with country.
    Issuing Agency Select the organization that issued the DI. You can select GS1, HIBCC, or ICCBBA.
    Primary DI Number Type the primary DI number. Ensure to follow the convention defined by the selected issuing agency.
    • For GS1, type a 14-digit number.
    • For HIBCC, type at least 6 characters comprising of numbers and alphabets. You can type up to 23 characters.
    • For ICCBBA, type 10 or 16 characters comprising of numbers and alphabets.
    Device Count Type the number of medical devices that are present in the base package.
    Unit of Use DI Number Type the unit of use DI number. Follow the conventions defined for the primary DI number.
    Note: This field is available only when the device count is more than one.
    DUNS Number Type the Data Universal Numbering System (DUNS) business number issued to the labeler by Dun & Bradstreet (D&B). The DUNS number is a nine-digit number.
    Device Description Type any additional information about the medical device.
    Commercial Distribution End Date Select the date after which the device will not be held or offered for sale. The device may not be available for purchase after this date.
    Device Subject to Direct Marking (DM) but Exempt Select Yes if the device is exempt from direct marking requirements under Code of Federal Regulations - Title 21 (21 CFR) 801.45. Otherwise, select No.
    DM DI Different from Primary DI Select Yes if the direct marking (DM) DI is different from the primary DI number.
    DM DI Number Type the direct marking DI number. Follow the conventions defined for the primary DI number.
    Note: You must provide a DM DI number if you select Yes in the DM DI Different from Primary DI field.
    Needs Review Select Yes if the device identification needs additional review. Otherwise, select No. If you select Yes, a route object is created between the Review and the Approved states.
    Note: You can modify this field only when the device identification object is in the Draft state.
    Automatic submission to Authority Select Yes if you want to send the submission file to the regularity authority automatically.

    Select No if you want to send the submission file the regulatory authority manually.

    Note: The fields Issuing Agency, Primary DI Number, DUNS Number, Brand Name, Version Or Model Number, Device Description, Published Date, Device Subject to Direct Marking but Exempt, DM DI Different from Primary DI, and Needs Review are mandatory.
  3. Click Done.
    The updated details are saved.