TM "Rehabilitimed" TUTOR-3N UNIp-3 Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" TUTOR-3N UNIp-3 Comfort
• Primary DI: 04823097723210
• Version / Model: TUTOR-3N UNIp-3 Comfort
• Catalog Number: TUTOR-3N UNIp-3 Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-17
• Public Version: 1
• Public Version Date: 2025-05-26
• Public Version Status: New
• Public Device Record Key: 721f63d0-9922-4355-98fa-9962044291aa

Device Description

Detachable knee brace, graphite color, provides external semi-rigid fixation of the knee joint in the extension position from the middle third of the thigh to the middle third of the shin, which eliminates the possibility of movements in the knee joint. Reinforced with 5 rigid tires with a system of independent fastening to the side surfaces of the brace and a system of six straps equipped with textile fasteners that ensure proper fit of the product to the body. Made of multilayer material with a cotton layer to the body and polyamide on the outside.

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: 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
ITM	Cage, Knee	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	04823097723210	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Child's age: up to 10 years
Device Size Text, specify			Tutor height (inch): 16,5