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U.S. FDA Medical Device Corneal Burr Requirements

FDA Medical Device Definition: A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Registrar Corp assists Corneal Burr companies with:

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