Hello All!
I am new to the medical device field. Our small start-up is branching out from medical device education, to actually selling the medical device itself. (Dental Implants) It has been a hell of a ride and now I feel like this is the right next step to continue to make our customers happy and provide a kick ass product.
My question is this:
One of the devices in this niche is an "accessory" to dental implants. There is nothing fancy or novel about it. It is conventionally used.
We purchase it from the manufacturer.
The manufacturer provides it to us sealed and labeled with UDI.
Their packaging is very ugly.
I want to tear open the packaging and put it into our own branded packaging. The label will remain essentially the same, but I will modify the size and font of the text for clarity to the end-user. Also, I will change the color of the package.
Do we use the same UDI that they provided?
Do we make a new UDI?
How do we make sure that we are properly approved to do this repackaging?
Probably all very novice questions. I would appreciate your help!!
I am new to the medical device field. Our small start-up is branching out from medical device education, to actually selling the medical device itself. (Dental Implants) It has been a hell of a ride and now I feel like this is the right next step to continue to make our customers happy and provide a kick ass product.
My question is this:
One of the devices in this niche is an "accessory" to dental implants. There is nothing fancy or novel about it. It is conventionally used.
We purchase it from the manufacturer.
The manufacturer provides it to us sealed and labeled with UDI.
Their packaging is very ugly.
I want to tear open the packaging and put it into our own branded packaging. The label will remain essentially the same, but I will modify the size and font of the text for clarity to the end-user. Also, I will change the color of the package.
Do we use the same UDI that they provided?
Do we make a new UDI?
How do we make sure that we are properly approved to do this repackaging?
Probably all very novice questions. I would appreciate your help!!
