Hello, I’m trying to understand the UDI and labeling procedures when building medical device kits and the requirements necessary. I’ve been looking into something called “convenience kits.” The instruments are reusable class I pieces.
The items will be packaged together in a kit, steel carrying tray enclosure. The instruments (not the tray) will be cleaned and sterilized by the end user before use on a patient. The instruments in the kit are not interchangeable and will remain together before and after use. This would not classify as a convenience kit I’m assuming?
Can it still be packaged with a UDI Device Identifier to encompass it as a complete medical device?
Does the package label need to list all the contents inside the kit or can I give it a simple device name?
The items will be packaged together in a kit, steel carrying tray enclosure. The instruments (not the tray) will be cleaned and sterilized by the end user before use on a patient. The instruments in the kit are not interchangeable and will remain together before and after use. This would not classify as a convenience kit I’m assuming?
Can it still be packaged with a UDI Device Identifier to encompass it as a complete medical device?
Does the package label need to list all the contents inside the kit or can I give it a simple device name?