FDA class 1

Today I got the following email from the FDA

Based on the device description you provided, our office of device evaluation believes this device does not seem to exceed the limitations of exemption; it can be regulated as a class I exempt device under 884.4530 as long as the device is remains in accordance with the class 1 exemption as explained in 21 CFR 844.4530.
ODE does not have any special labeling requirement specific to these devices.

This is what I anticipated hearing, that this device requires no specific labeling or regulatory over site and we can go ahead and make it in a proper manufacturing facility and sell it through distribution channels appropriate for sterile medical equipment. Getting this confirmation is very satisfying.