DONJOY PERFORMANCE

Basic Information

• Brand Name: DONJOY PERFORMANCE
• Primary DI: 00190446299462
• Version / Model: DP181EB01-BLK-L
• Company Name: DJO, LLC
• Labeler DUNS: 081840873
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-20
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 23670347-667e-45f9-9e71-09519c7aa881

Device Description

DJP BIONIC ELBOW BRACE II, BLACK, LARGE

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: No
• 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
IQI	ORTHOSIS, LIMB BRACE	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
Primary	00190446299462	GS1