LOT or Serial Number Symbol not used when the information is contained in the UDI?

Q

QARA93

Registered
#1
#1
Dear all,

As the serial number or lot number is embedded in the UDI-PI, and is identifiable in the human readable section of the UDI (under "(11)" or" (10)"), is it necessary to also include the LOT or SN symbol in the product label (followed of course by the identifier)? Would it be justifiable to not include it if there are space limitations on the product label?


Thanks!
 
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shimonv

shimonv

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#2
#2
As long as you are selling the device in the US market, where UDI is recognised, I don't think you you need to include the serial/lot number as a separate symbol. The information contained in the device identifier fulfils the regulatory requirement of 21 CFR 801.

Shimon
 
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