Sterile barrier system symbols - Label redlines for a Class III device (Kit Box)

kunal9218

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#1
Hi,

I am working on label redlines for a Class III device. The level of packaging is a convenience kit box. The kit box acts as a protective layer to the sterile barrier system inside (Pouch) and when the sterile barrier is opened, there is another protective tyvek packaging which is introduced in the sterile field. So this is how it is: Protective packaging-Sterile barrier(Pouch)-Protective packaging (sterile field).

Now, I have a question: Should any symbol be placed on the Kit box or it is OK because there is a symbol on the Sterile barrier (which is the pouch)?

TIA.
 
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