Iris Hook

Basic Information

• Brand Name: Iris Hook
• Primary DI: GYNX32100
• Version / Model: 3210
• Company Name: GYNEX CORPORATION
• Labeler DUNS: 012997685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b2611f2d-f7ad-4468-a84e-8321fa8acf5d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HDC	Tenaculum, Uterine	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32598	Uterine fibroid hook	A shaft-like surgical instrument whose distal end tapers to form a hook or multiple hooks used to fix or apply traction to uterine fibroids during a gynaecological procedure. It is typically a one-piece instrument made of high-grade stainless steel with a handle at the proximal end that is available in various shapes. In multiple hook designs, the hooks are in parallel. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	GYNX32100	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K980247	000