Re: Country of Origin Marking on Retail Packaging
The fundamental requirement, as stated at 19CFR 134.3, is that the "article (or its container)" be so marked.
If the article is a medical device and directly carries a label, and the country of origin is marked on that label, the requirement is satisfied and there is no further requirement.
If the device itself can't be labeled because of size, material type or some functional requirement but the pouch or label in which the device is distributed is labeled, the requirement is satisfied.
I don't know of any requirement that an IFU additionally must be labeled.
Keep in mind that this is a CBP rule, legally separate from the FDA's rules and enforcement procedures.