celticfrosting
Starting to get Involved
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?