I have searched and can not find a definitive answer on this for US. My company wants to distribute needles and syringes, class II devices. We are only distributing, label does not have our name (manufactured in China). Manufacturer is registered and has 510k. I received the product samples and there is no UDI. Can I distribute? I would think not as it’s not approved for distribution in the US due to the lack of UDI but has 510k. What are my requirements/liability for distributing unapproved product?