Orion Headed Screw System Instruments

Basic Information

• Brand Name: Orion Headed Screw System Instruments
• Primary DI: M695HTR040092470
• Version / Model: HTR-04-009247
• Catalog Number: HTR-04-009247
• Company Name: Tyber Medical LLC
• Labeler DUNS: 010968002
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-23
• Public Version: 1
• Public Version Date: 2019-09-02
• Public Version Status: New
• Public Device Record Key: 3cbcdc2b-67c1-44b4-853e-ec3d9e4da0c3

Device Description

6.5 Screw Countersink

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWW	COUNTERSINK	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	M695HTR040092470	HIBCC

Customer Contacts

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