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U.S. FDA Medical Device Intestine Bag Requirements

FDA Medical Device Definition: An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

Registrar Corp assists Intestine Bag companies with:

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