Properties of a Product Identification

The Properties page of a product identification provides the details about the ASPI that is created for the product.

Required Access Roles:

  • App-specific: Product Manager
  • Baseline: Leader

To access this page:

This page discusses:

Fields

Field Name Description
Owner The owner of the ASPI.
Policy The policy of the object.
State The lifecycle state of the object.
Originated The date on which the ASPI is created.
Modified The date on which the ASPI is modified.
Region The region in which the ASPI is created. This field is present if the ASPI is created for the selected region.
Country The country in which the ASPI is created. This field is present only if the ASPI is created for USA.
Class The risk category, which is displayed as class for the ASPI.
Human Cell, Tissue or Cellular or Tissue-Based Product Whether the device is created using the human tissues. If it is created using the human cell, tissue, the value is displayed as Yes. Otherwise No.
Animal Tissue Whether the device is created using the animal tissues. If it is created using the animal tissues, the value is displayed as Yes. Otherwise No
Device Exempt from Premarket Submission Whether the ASPI is exempted from the premarket submission or conformity assessment. If it is exempted, the value is displayed as Yes. Otherwise No.
Medical Purpose The medical purpose for which the ASPI is created.
Authorized Representative The contact for which the type is added as Authorized Representative.
Related ASPI The related ASPI that is added from the same country or region to the context ASPI.
Kit The kit that is used to create the ASPI. If it is used, the value is displayed as Yes. Otherwise No.
Combination Product The combination used to create the ASPI. If it is used, the value is displayed as Yes. Otherwise No.
The following fields are present if the ASPI is created for the EU region:
Issuing Agency The name of the issuing agency.
DI Number The DI number.
Device Type The type of device.
Applicable Legislation The legislation that is applicable for the device.
Special Device The device that is created for the special purpose.
Device Applicability The device that is applicable for the usage.
Declaration Of Conformity The document that contins the conformity declaration.
Note: If the declaration of conformity is connected to the context ASPI, then it ned to be in the Released state to promote the sASPI to the Approved state.
Summary of Safety and Clinical Performance The detailed summary of the safety and clinical performance of the device.
URL The URL releted to the safety and clinical performance of the device.

Actions and Toolbar Commands

Action Description
Submit to Review Promotes the ASPI objects from the In Work to the Review state.
Note: This option is present if the ASPI is in the In Work state.
Submit to Approved Promotes the ASPI objects from the Review to the Approved state.
Note: This option is present if the ASPI is in the Review state.
Submit to Released Promotes the ASPI objects from the Approved to the Released state.
Note: This option is present if the ASPI is in the Released state.
Revise Lets you create the revision of the ASPI.
Note: This option is present if the ASPI is in the Released state.
Edit Lets you edit the details of the ASPI. For more information, see Editing the Product Identification Details.