TM "Rehabilitimed" TUTOR-6K-VU UNI Right

Basic Information

• Brand Name: TM "Rehabilitimed" TUTOR-6K-VU UNI Right
• Primary DI: 04823097722794
• Version / Model: TUTOR-6K-VU UNI Right
• Catalog Number: TUTOR-6K-VU UNI Right
• 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: 5ac4f147-26dd-47c5-b528-d97fa2d090e2

Device Description

Black wrist-hand orthosis, designed for complete fixation of the radiocarpal joint and thumb, provides external semi-rigid dosed fixation of the distal third of the forearm and radiocarpal joint, and the thumb in the abduction position. Reinforced with two metal profiled splints, one at an angle of 60 degrees to the hand relative to the forearm, located along the palm, the second at an angle of 0 degrees to the thumb in the abduction position. 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
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41459	Wrist/hand orthosis	An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097722794	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			Wrist circumference (inch): 6-10