Hello, we are a distributor of medical devices and we would like to create a convenience kit of sterile components(not manufactured by us) the medical devices are already sterile and packaged individually and bear their own UDI.
We do not intend to sterilize again the medical device. Just put them together in a box and label the box with its own UDI. My question is for the serility aspect . We do not intend to sterilize the KIT so are we allowed to have a KIT that wont be labelled as sterile but composed of sterile components please?
We will put all the required info regarding the kit on its label and add that this kit contains and list the medical devcies included and add the sterile logo next to it.
So basically are we allowed to have a convenience kit non sterile composed of sterile components please?Thanks
We do not intend to sterilize again the medical device. Just put them together in a box and label the box with its own UDI. My question is for the serility aspect . We do not intend to sterilize the KIT so are we allowed to have a KIT that wont be labelled as sterile but composed of sterile components please?
We will put all the required info regarding the kit on its label and add that this kit contains and list the medical devcies included and add the sterile logo next to it.
So basically are we allowed to have a convenience kit non sterile composed of sterile components please?Thanks
