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U.S. FDA Medical Device Surgical Marking Pen Requirements


FDA Medical Device Definition: An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

Registrar Corp assists Surgical Marking Pen companies with:

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