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U.S. FDA Medical Device Uterine Packer Requirements

FDA Medical Device Definition: An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.(3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.(5) A uterine clamp is an instrument used to hold the uterus by compression.(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.(7) A vaginal applicator is an instrument used to insert medication into the vagina.(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.

Registrar Corp assists Uterine Packer companies with:

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