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U.S. FDA Medical Device Ureteral Stone Dislodger Requirements


FDA Medical Device Definition: A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger

Registrar Corp assists Ureteral Stone Dislodger companies with:

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