ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113680545
• Version / Model: ManaEZ Hinged Knee Brace X-Large
• Catalog Number: EZHK1820XL
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-20
• Public Version: 2
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: 49af77fe-5b70-4b79-b64b-a17a304da026

Device Description

The ManaEZ Hinged Knee is a convenient wrap on hinged sleeve. The open popliteal feature allows for a comfortable fit. Wrap feature for easy on and off application High quality neoprene Open popliteal

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
41065	Knee support orthosis	A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113680545	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]