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U.S. FDA Medical Device Corneo-Scleral Punch 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 Corneo-Scleral Punch companies with:

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