Serial Number labeling for Class IIa Medical device packaged in multi-pack

L

leroybrown

#1
I want to package 3 class IIa medical devices together. They are the same device but in 3-pack form. How do I label it as far as the serial number goes? Can I just reference the individual devices for the serial number or do I have to include all 3 SN's on the label?
 
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R

Rolande Hall

#2
I want to package 3 class IIa medical devices together. They are the same device but in 3-pack form. How do I label it as far as the serial number goes? Can I just reference the individual devices for the serial number or do I have to include all 3 SN's on the label?
The storeman cannot open a package to get the trace code off each item!
I faced a similar issue some time ago and decided that in order to permit the maintainance of traceability records that all serial numbers must appear on the labelling.
Good luck with your project.
 
L

leroybrown

#3
Thanks! That's what I figured. One can always hope there is some secret way around all these regulations. :)
 
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