UDI is a unique device identification system created and regulated by the US Food and Drug Administration (FDA).
It is designed to adequately identify medical devices through their distribution and use.
When implemented, most medical devices will include a unique device identifier in human and machine-readable form.
When required, these identifiers must appear on labels and packaging and on devices in the case of repeatedly used equipment (i.e. surgical tools, instruments) which has to be marked directly.
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