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U.S. FDA Medical Device Cartridge Syringe Requirements: Cartridge Syringe

FDA Medical Device Definition: A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient

Registrar Corp assists Cartridge Syringe companies with:

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

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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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