Status Page

This page displays the additional information about the device identifier (DI). It displays kit details, codes, listing number, and premarket exemption details. This tab is displayed only DIs that are created for the USA.

Required Access Roles:

  • App-specific: Product Manager
  • Baseline: Leader

To access this page:

This topic describes:

This page discusses:

Fields

Field Name Description
Owner The person who is responsible for the DI.
Originator The person who has created the DI.
Policy The policy of the object.
Status The current status of the DI.
Originated The date on which the DI is created.
Modified The date on which the DI is modified.
Country The country in which the product is distributed.
Product Code Three-letter classification code issued by the regulatory authority for premarket devices. Click to add another product code.
FDA Listing Number Seven-digit number assigned by FDA to devices in commercial distribution irrespective of the premarket authorization requirements defined in 21 CFR 807.28(f). Click to add another listing number.
FDA Preferred Term Code A unique four-letter code created by the FDA to assign to a GUDID submission if a GMDN PT Code is unavailable.

Actions

Action Description For More Information
> Revise Creates a revision for the DI. The revised DI has the same DI number with one added to the previous DI. The first revised DI is with revision one and on revising it, the new DI is created with revision two and so on.

Only a Product Manager can revise a DI. Only some attributes of a DI can be changed during the revision.

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> Clone Creates a copy of the selected device identification object. All details except the primary DI number are copied.
Note: The selected objects must be in the Draft state or the Review state.
Cloning a Device Identification
> Submit To Review Promotes the device identification object from the Draft state to the Review state. -
> Validate Device Lets you validate the selected DI. The validation report is displayed according to the regulatory authority for which the context DI is created. The report lists all the validations that are need to complete. -
> Submit To Approved Promotes the device identification object from the Review state to the Approved state.
Notes:
  • Provide information in all the mandatory fields in the Device Information page, Device Status page, and the Device Characteristics page.
  • Create at least one package device identifier and one contact.
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> Publish To Authority Generates submission file for the selected device identification object and submits it to the regulatory authority. Submitting Device Identification to Regulatory Authority Through AS2 Gateway
Summary Report Generates a summary report for the selected device identification object. Summary Report
> Transfer Ownership Transfers the device identification object to the required user. Transferring a Device Identification
Edit Activates edit mode in which you can modify all the device status fields. Modifying Device Status Details