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Understanding the UDI Format A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following: Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
How do I get an UDI?
The UDI must be issued under a system operated by an FDA-accredited issuing agency. The issuing agency does not necessarily create each UDI, rather the issuing agency will assign a unique company identifier and provide guidance on the creation and maintenance of UDIs.
What is a UDI used for?
Providing a standardized identifier that will allow manufacturers, distributors, and health care facilities to more effectively manage medical device recalls. Providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
What are the benefits of UDI?
Benefits of the UDI System include improved inventory management, enhanced traceability, reduced patient safety incidents, regulatory compliance, and cost savings. However, implementing the UDI System can be challenging, requiring changes to labeling infrastructure and adherence to FDA regulations.
What does the UDI include?
The HDI is a summary measure of human development. How is it defined? The HDI is a summary composite measure of a countrys average achievements in three basic aspects of human development: health, knowledge and standard of living.
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