Leigh76
Registered
I have a unique situation and can't find a specific answer.
I have a Class II reusable accessory and the labeling requirements per FDA have me stumped.
The device is a mounting bracket that allows hospitals to mount the capital unit to a wall in the OR. Nonsterile, not re-processable. It's literally a piece of metal and some screws. It is sold separately and on its own.
Labeling is currently:
Outer Carton with label
Inner poly bag that contains parts with no label on the bag.
Are we out of compliance by not having a label on the inner poly bag? Do such products require direct marking?
Any thoughts are appreciated as I am at a loss here.
I have a Class II reusable accessory and the labeling requirements per FDA have me stumped.
The device is a mounting bracket that allows hospitals to mount the capital unit to a wall in the OR. Nonsterile, not re-processable. It's literally a piece of metal and some screws. It is sold separately and on its own.
Labeling is currently:
Outer Carton with label
Inner poly bag that contains parts with no label on the bag.
Are we out of compliance by not having a label on the inner poly bag? Do such products require direct marking?
Any thoughts are appreciated as I am at a loss here.