T25 DRIVER, SQUARE

Basic Information

• Brand Name: T25 DRIVER, SQUARE
• Primary DI: 00810097802377
• Version / Model: 101-0022
• Catalog Number: 101-0022
• Company Name: Osteocentric Technologies, Inc.
• Labeler DUNS: 089645059
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-17
• Public Version: 2
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 7e96d981-66a4-45b8-8572-303fd3ad58f9

Device Description

T25 DRIVER, SQUARE

Device Characteristics

• Single Use: Yes
• 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: 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
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47779	Orthopaedic instrument surgical connector	A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810097802377	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221332	000