Device Characteristics Page

This page displays the additional information about the Device Identifier (DI). It displays batch and serial numbers, dates, prescription details, and sterilization details.

To access this page:

  1. From the Device Identification List page or the Device Identification Home Page, click the required DI number.
  2. Select the Device Characteristics category.

This page discusses:

Fields

Field Name Description
Owner Name of the owner for the device identification object.
Originator Name of the person who created the device identification object.
Policy The policy that governs the lifecycle of the product.
State State of the device identification object. Possible states are Draft, Review, Approved, Submitted, and Publish.
Originated Date when the device identification object was created.
Modified Date when the device identification object was last modified.
Country The country in which the product is distributed.
Region The region in which the product is distributed.
Production Identifier The identifiers that are used in the production of the device. It has the below values:
  • Expiration Date
  • Lot or Batch Number
  • Manufacturing Date
  • Serial Number
  • Software Indication. This option is available for the device that is created in EU.
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes: The product or its packaging contains natural rubber as defined in 21 CFR 801.437.

No: The product or its packaging does not contain natural rubber.

Prescription Use (Rx)

Yes: A prescription is required to purchase the product.

No: A prescription is not required to purchase the product.

Over the Counter (OTC)

Yes: A prescription is not required to purchase the product.

No: A prescription is required to purchase the product.

MRI Safety Status Status of the MRI safety testing. Possible values are MR Conditional, MR Safe, MR UnSafe, and Labeling does not contain MRI Safety Information. If the value given is Labeling does not contain MRI Safety Information, it can be changed to other values even after the grace period.
Sterilization Method Sterilization method that must be performed on the device before use.
Donation Identification Number Indicates that the device is managed by a Donation Identification Number (DIN). DIN is assigned to each donation and is printed on the device label or packaging. DIN is also applicable for devices that are classified as Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/Ps). DIN has value Yes for ICCBBA and No for others. DIN is non editable.
Production Identifier The identifiers that are used in the production of the device. It has the below values:
  • Expiration Date
  • Lot or Batch Number
  • Manufacturing Date
  • Serial Number
  • Software Indication. This option is available for the device that is created in EU.
Maximum Number of Reuse Whether the device can be used for maximum numberof times. If it is displayed the number.
URL for additional information The URL details in which the instructions are mentioned to use the device.
Non Medical Purpose Whether the device is created for the non-medical purpose. If it is created, one of the foloowing options are displayed;
  • Brain Electrostimulation
  • Contact Lenses
  • EMR
  • Filling By Injection
  • Product In Body
  • Equipment For Adipose Tissue

Actions

Action Description For More Information
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. --
Submit To Approved Promotes the device identification object from the Review state to the Approved state.
Notes:
  • You must provide information in all the mandatory fields in the Device Information page, Device Status page, and the Device Characteristics page.
  • You must 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 characteristics fields. Modifying Device Characteristics Details