'Virtual' UDI-DI for single use medical device?

Fjalar

Registered
We have a single-use medical device packaged in a quantity of 30 units(never sold separately). Only the package has a UDI-DI, not the individual units. Do the individual units (devices) need to have their own (virtual) UDI-DI, even if this 'virtual' UDI-DI will not be placed on the label anywhere?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Single-use devices distributed in a single package intended to be used immediately after opening do not require each device to have its own UDI if the package has a UDI-DI and the individual units are not sold separately. This is applicable if the devices are meant to remain in the package until used.
 

yodon

Leader
Super Moderator
That means, I think, that there's nothing (no UDI) with the 'PI' information (manufacturing date, lot number, etc.), right? And that's ok?
 
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