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U.S. FDA Medical Device Ribdam Requirements


FDA Medical Device Definition: A ribdam is a device that consists of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine drainage is expected.

Registrar Corp assists Ribdam companies with:

  • FDA Ribdam Establishment Registration
  • FDA Ribdam Listing
  • FDA Ribdam Label Requirements and Exceptions
  • FDA Ribdam Import Information
  • FDA Ribdam Detentions (Ribdam Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Ribdam Manufacturers (Ribdam Suppliers)
       - Ribdam Distributors
       - Ribdam Processors
       - Ribdam Repackers
       - Ribdam Relabelers
       - Ribdam Exporters
       - Ribdam Importers
For more information about Ribdam Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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