Can someone please help me to understand this data submitted to GUDID by manufacturer. I think there are mistakes or am I just confused? I am attaching screenshots. It says Device count 1. In GMDN it says it's biliary stent, in FDA product code it says NIP which is a code for superficial femoral artery stent. FDA code for biliary stent is FGE.
So my first question when this dismatch of codes is possible/acceptable?
In Additional Identifiers it states there is no Unit of use DI. When I go to Device record history in public versions 2 and 3 it shows there is unit of use DI 10705032025055 and device count is 2. In public version 4 there is no unit of use and device count is 1.
How is that it stated on the device page that device count is 1 and no units of use and in the history it shows there was unit of use and device count was 2 and in the final version it was changed to no units of use and device count 1? In what situations this is possible? How the unit of use disappeared?
I am just learning so all of this looks to me as errors but maybe it's because of lack of knowledge. Please help to understand.
So my first question when this dismatch of codes is possible/acceptable?
In Additional Identifiers it states there is no Unit of use DI. When I go to Device record history in public versions 2 and 3 it shows there is unit of use DI 10705032025055 and device count is 2. In public version 4 there is no unit of use and device count is 1.
How is that it stated on the device page that device count is 1 and no units of use and in the history it shows there was unit of use and device count was 2 and in the final version it was changed to no units of use and device count 1? In what situations this is possible? How the unit of use disappeared?
I am just learning so all of this looks to me as errors but maybe it's because of lack of knowledge. Please help to understand.
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