MECRON Elbow Splint OA: 300 - 350 mm

Basic Information

• Brand Name: MECRON Elbow Splint OA: 300 - 350 mm
• Primary DI: 00609271950641
• Version / Model: OS030202
• Catalog Number: OS030202
• Company Name: Darco (Europe) GmbH
• Labeler DUNS: 343551081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 2
• Public Version Date: 2025-06-30
• Public Version Status: Update
• Public Device Record Key: 7e2e24a4-29a5-4157-b247-93b49fe8b041

Device Description

M Blue

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IOY	SUPPORT, ARM	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41053	Elbow orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10609271950648	GS1	Box	12	In Commercial Distribution
Primary	00609271950641	GS1