TM "Rehabilitimed" OT-2 UNI Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" OT-2 UNI Comfort
• Primary DI: 04823097717585
• Version / Model: OT-2 UNI Comfort
• Catalog Number: OT-2 UNI Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-05
• Public Version: 1
• Public Version Date: 2025-05-13
• Public Version Status: New
• Public Device Record Key: 28ba5ce7-d838-4916-a202-5b855a5bb385

Device Description

It is a graphite-colored shoulder brace. The posture corrector is presented in the form of two shoulder straps made of soft material, which are worn on the shoulder joints in the form of rings and, crossing, are tightened on the back in the form of a fabric figure eight on a round pad located in the interscapular region using a Velcro fastener at the ends of the shoulder straps.

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
IQJ	Splint, Clavicle	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13810	Clavicle orthosis	A prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It incorporates padded straps that loop over each shoulder, under each arm, and around the back (e.g., figure-of-eight harness). This device may also be used to improve the patient's posture. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097717585	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			Chest circumference (cm): below 100