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U.S. FDA Medical Device Ostomy Size Selector Requirements

FDA Medical Device Definition: An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

Registrar Corp assists Ostomy Size Selector companies with:

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