Artemis Proximal Femoral Nail System

Basic Information

• Brand Name: Artemis Proximal Femoral Nail System
• Primary DI: 18400659001813
• Version / Model: T5-0540-000
• Catalog Number: T5-0540-000
• Company Name: Glw, Inc.
• Labeler DUNS: 081102081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-30
• Public Version: 2
• Public Version Date: 2026-03-12
• Public Version Status: Update
• Public Device Record Key: ceda3b3a-4ebd-4ec3-b7ea-6c4f374a9890

Device Description

Artemis Proximal Femoral Nail System, K-Wire, Drill Tip, ø3.5mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
35436	Manual wire driver	A hand-held manual surgical instrument (drill-like) designed to drive orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different thickness that are pointed for self-drilling) into fractured/deformed bones for their restoration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18400659001813	GS1