Kelly Tenaculum 4X5 Teeth 9" (229mm)

Basic Information

• Brand Name: Kelly Tenaculum 4X5 Teeth 9" (229mm)
• Primary DI: M803031017
• Version / Model: Kelly Tenaculum 4X5 Teeth 9" (229mm)
• Catalog Number: 031017
• Company Name: MEDGYN PRODUCTS, INC.
• Labeler DUNS: 103913430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-16
• Public Version: 1
• Public Version Date: 2025-11-24
• Public Version Status: New
• Public Device Record Key: 5a194c9e-ef7c-4c8f-bfb4-d6abcff51387

Device Description

Kelly Tenaculum 4X5 Teeth 9" (229mm)

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13998	Uterine tenaculum	A hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M803031017	HIBCC