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V. Mueller GU4010-022 Van Buren Urethral Sound Item 1405Location 0470 eBay Required - FDA Disclaimer - Any Healthcare Category or Medical Device Listing: The sale of this item MAY be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. This item has been cleaned and handled in accordance with the manufacturer's instructions. If the item was subject to FDA regulation, then we would have to file with the FDA before any verification would commence; such as your status as an authorized purchaser. If you have any questions please contact us or you may refer to the FDA website: www.fda.gov FDA - Medical Devices; Device Regulation and Guidance; Registration and ListingThe following establishments DO NOT need to register, list and/or pay fee: (1) Import Agent, Broker, and Other Parties who do not take first possession of a device imported into the United States; (2) Manufacturer of Components, that are not otherwise classified as a finished device, that are distributed only to a finished device manufacturer (807.65a applies); (3) Refurbishes or Remarketers of Used Devices already in Commercial Distribution in the United States; (4) Specification Consultant Only; (5) Wholesale Distributor that is not a Manufacturer or Importer; "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 Device has been cleaned, sterilized and handled to the manufacturer's standards." Hooli, LLC23941 County Road 10Bovey, MN 55709(218) 256-0628