Hayden Medical

Basic Information

• Brand Name: Hayden Medical
• Primary DI: 00840319733431
• Version / Model: 365-203
• Catalog Number: 365-203
• Company Name: Hayden Medical, Inc.
• Labeler DUNS: 618214410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-12
• Public Version: 1
• Public Version Date: 2022-09-20
• Public Version Status: New
• Public Device Record Key: 51171481-f501-4c63-90fb-939d8d2bedfc

Device Description

Hulka Uterine Mobilizer/Tenaculum 11-1/4" (28.1cm)

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: 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: 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
PUA	Tenaculum, uterine, exempt	Obstetrics/Gynecology	884.4530	2

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	00840319733431	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]