Eleganz Fusion Screw System

Basic Information

• Brand Name: Eleganz Fusion Screw System
• Primary DI: 00810190980774
• Version / Model: DI-2040
• Company Name: Dev4
• Labeler DUNS: 119211016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-01
• Public Version: 1
• Public Version Date: 2025-10-09
• Public Version Status: New
• Public Device Record Key: bca590f8-2f31-45ef-a225-a211f94d8d0a

Device Description

0.8mm Kirschner wire

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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66935	Orthopaedic intraoperative positioning pin, single-use	A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810190980774	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K250251	000