Per Ebay: "The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."  This medical device has been used and has not been altered.  The item will be properly cleaned and sterilized (where required) before shipment."  Kroslak Enterprises Inc.  Riverview, FL.  BY PURCHASING YOU ACKNOWLEDGE TO BE AN AUTHORIZED BUYER.