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U.S. FDA Medical Device Ophthalmic Manual Trephine 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 Ophthalmic Manual Trephine companies with:

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