TRUELOK SYSTEM

Basic Information

• Brand Name: TRUELOK SYSTEM
• Primary DI: 18059015376029
• Version / Model: 1
• Catalog Number: 99-50-2510
• Company Name: ORTHOFIX SRL
• Labeler DUNS: 438793622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-10
• Public Version: 3
• Public Version Date: 2025-10-24
• Public Version Status: Update
• Public Device Record Key: 0fab6195-2dec-456a-a35c-cfbca6594c91

Device Description

TL STRAIGHT TUBE WRENCH 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXC	Wrench	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32871	Surgical torque wrench, reusable	A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	18059015375954	GS1
Primary	18059015376029	GS1

Customer Contacts

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