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U.S. FDA Medical Device Depth Gauge Requirements

FDA Medical Device Definition: A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

Registrar Corp assists Depth Gauge companies with:

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