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

Basic Information

• Brand Name: TM "Rehabilitimed" TUTOR-6K-VU UNI Left
• Primary DI: 04823097708439
• Version / Model: TUTOR-6K-VU UNI Left
• Catalog Number: TUTOR-6K-VU UNI Left
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-04
• Public Version: 1
• Public Version Date: 2025-05-12
• Public Version Status: New
• Public Device Record Key: 68e62e3c-60f8-4ee9-80b2-1b68a964cf4c

Device Description

It is a wrist and thumb joint fixator, black. Made of elastic, breathable material, effectively maintains the temperature balance of the skin. Reinforced with two metal profiled tires that completely limit movement in the thumb and wrist joints. Tightening straps with textile fasteners on the forearm and thumb fix in the optimal position and support the tendons of the flexors and extensors of the hand.

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	04823097708439	GS1

Customer Contacts

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