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U.S. FDA Medical Device Surgical Contractor Requirements


FDA Medical Device Definition: A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Registrar Corp assists Surgical Contractor companies with:

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