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 Listing
The 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."