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U.S. FDA Medical Device Vein Extractor 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 Vein Extractor companies with:

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