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U.S. FDA Medical Device Orchidometer 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 Orchidometer companies with:

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