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U.S. FDA Medical Device Ureteral Stylet Requirements

FDA Medical Device Definition: A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Registrar Corp assists Ureteral Stylet companies with:

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