M
We're being asked to make a disposable screen pointer, used by surgeons for touch screen monitor interface during invasive procedures to avoid contaminating their monitor screen.
This device has no patient contact. It's sold sterile, because of course the surgeon touches it.
It's not a pen. It has no marking capability. It's also not a surgical instrument per se.
It's presently for sale, made elsewhere. Apparently it's considered Class I...there doesn't appear to be a 510(k).
Anyone have any ideas as to Product Code? I think it's a medical device, but I'm a bit stumped as to how to classify it. I'm not eager to have to file for a new code if that can be avoided.
This device has no patient contact. It's sold sterile, because of course the surgeon touches it.
It's not a pen. It has no marking capability. It's also not a surgical instrument per se.
It's presently for sale, made elsewhere. Apparently it's considered Class I...there doesn't appear to be a 510(k).
Anyone have any ideas as to Product Code? I think it's a medical device, but I'm a bit stumped as to how to classify it. I'm not eager to have to file for a new code if that can be avoided.