Sale of medical devices are regulated at the state level, not by the FDA. Not all states require a distributor to be licensed to sell these products; however, many do. See the FDA’s website for your specific state here.
5-Line is headquartered in NJ. NJ requires a Wholesale Drug and Device license - ours is 5005403.
If you are a physician in NJ, you can verify your NJ distributor here.
With 50 different states and 50 different sets of regulations it is important for you as a customer and a clinician to understand who you are working with.
Click here for the latest FDA Regulations for Human Cells, Tissues and Cellular and Tissue-Based Products.