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U.S. FDA Medical Device Surgical Sponge Counter Requirements


FDA Medical Device Definition: A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

Registrar Corp assists Surgical Sponge Counter companies with:

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