Gynex

Basic Information

• Brand Name: Gynex
• Primary DI: GYNX293001
• Version / Model: 29-300
• Company Name: GYNEX CORPORATION
• Labeler DUNS: 012997685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2023-12-26
• Public Version: 1
• Public Version Date: 2024-01-03
• Public Version Status: New
• Public Device Record Key: a8917f07-0d7f-4d10-a787-6a6a5d4230d8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61480	Intrauterine device thread extractor	A hand-held manual instrument intended to be used to locate and extract the threads of an intrauterine device (IUD) through the cervical os from within the uterine cavity. It is made of plastic materials and typically takes the form of a shaft with hook-like notches along the distal portion. It may subsequently be used to extract the IUD. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	GYNX292000	HIBCC
Primary	GYNX293001	HIBCC