U.S. FDA Medical Device Gastro-Urology 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).
FDA Gastro-Urology Stylet Establishment Registration
FDA Gastro-Urology Stylet Listing
FDA Gastro-Urology Stylet Label Requirements and Exceptions
FDA Gastro-Urology Stylet Import Information
FDA Gastro-Urology Stylet Detentions (Gastro-Urology Stylet Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Gastro-Urology Stylet Manufacturers (Gastro-Urology Stylet Suppliers)
- Gastro-Urology Stylet Distributors
- Gastro-Urology Stylet Processors
- Gastro-Urology Stylet Repackers
- Gastro-Urology Stylet Relabelers
- Gastro-Urology Stylet Exporters
- Gastro-Urology Stylet Importers
For more information about Gastro-Urology Stylet Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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