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  • 1.  UDI Label and Serial Number Label

    Posted 02-May-2022 16:05
    Hello All, 

    Currently, we put UDI labels on our devices which include the GTIN, Manufacture Date, and Serial Number. In addition, we have a separate label that is also applied, which has just the device serial number. Since our UDI Label has the Serial Number incorporated, could we do away with the separate Serial Number Label? I am thinking we could as it is redundant but wanted to get thoughts from others who may think of potential issues that could arise. 

    Thank you for your time and attention!

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    Rebecca Tucek
    Melbourne FL
    United States
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  • 2.  RE: UDI Label and Serial Number Label

    Posted 03-May-2022 16:56
    Hello 
    The serial # on the UDI label should be enough and you can use it to upload in FDA GUDID database. if both serial numbers are the same then it is redundant​

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    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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    Original Message


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