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U.S. FDA Medical Device Non-Powered Rectal Probe Requirements

FDA Medical Device Definition: A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

Registrar Corp assists Non-Powered Rectal Probe companies with:

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