MECRON Knee Flexion Clinical L:500mm, OS:590mm, US:380mm

Basic Information

• Brand Name: MECRON Knee Flexion Clinical L:500mm, OS:590mm, US:380mm
• Primary DI: 00609271951679
• Version / Model: OH500404A
• Catalog Number: OH500404A
• Company Name: DARCO INTERNATIONAL, INC.
• Labeler DUNS: 184231298
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 1
• Public Version Date: 2023-02-16
• Public Version Status: New
• Public Device Record Key: e719e503-226e-4f8a-900f-7a572163f131

Device Description

XL Black

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITQ	JOINT, KNEE, EXTERNAL BRACE	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12099	Knee immobilizer	A rigid support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10609271951676	GS1	Box	12	In Commercial Distribution
Primary	00609271951679	GS1