Cannulated Headless Screw - Full Thread

Basic Information

• Brand Name: Cannulated Headless Screw - Full Thread
• Primary DI: 00196449024711
• Version / Model: 03.333.925S
• Company Name: Tyber Medical, LLC
• Labeler DUNS: 010968002
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-24
• Public Version: 2
• Public Version Date: 2025-08-15
• Public Version Status: Update
• Public Device Record Key: 54c418db-0358-4912-9a92-d5361b92a5c1

Device Description

CANN CNTRSNK F/3.5/4.0MM HDED CANNULATED SCREW QC, REUSABLE STERILE

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic manual surgical instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00196449024711	GS1

Customer Contacts

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