ELOS

Basic Information

• Brand Name: ELOS
• Primary DI: 08056693001024
• Version / Model: 200.4001
• Catalog Number: 200.4001
• Company Name: INTRAUMA SPA
• Labeler DUNS: 387588051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 1
• Public Version Date: 2023-09-20
• Public Version Status: New
• Public Device Record Key: 0969008c-c753-410f-8342-dfc0a6cbe012

Device Description

Long Nail, LEFT

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33187	Femur nail	A rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056693001024	GS1

Premarket Submissions

Submission Number	Supplement Number
K201147	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			CCD angle: 127°
Outer Diameter	10	Millimeter
Length	400	Millimeter
Device Size Text, specify			Side: LEFT