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