TM "Rehabilitimed" L-4M-3V XXL Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" L-4M-3V XXL Comfort
• Primary DI: 04823097717097
• Version / Model: L-4M-3V XXL Comfort
• Catalog Number: L-4M-3V XXL 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: d9f0b331-d6c8-4daf-a685-fdb84a642b11

Device Description

It is an orthopedic corset of medium fixation in graphite color. The part of the corset adjacent to the back is made of multilayer material (cotton twill tripled (glued in a special way with polyurethane foam) with cotton terry cloth), the front and side parts of the corset are made of elastic bandage cloth and are equipped with 4 metal stiffeners that are equipped with a set of 2 stiffeners with magnetic elements (they are plastic stiffeners with magnetophores applied to them). Equipped with two additional elastic belts for enhanced fixation.

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
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66086	Multiple spinal region orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, sprains, or strains of the spine, and may additionally provide support for the abdomen. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097717097	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			Hips 10 cm below the waistline (cm): 113-120
Device Size Text, specify			Corset length (cm): 123-127