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

Basic Information

• Brand Name: TM "Rehabilitimed" L-4M-3 M Comfort
• Primary DI: 04823097717189
• Version / Model: L-4M-3 M Comfort
• Catalog Number: L-4M-3 M 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: 6852e8d5-c875-46dd-b3c4-e7f9c0f4ccc9

Device Description

Orthopedic device of graphite color, for the lumbar and sacral spine, medium degree of fixation with metal stiffeners allows to achieve a high stabilizing effect by providing external semi-rigid fixation, made of elastic multilayer material (cotton twill tripled fabric (glued in a special way with polyurethane foam) with gabardine fabric), which ensures the stability of the location of 4 powerful modeled duralumin stiffeners. Complete with a set of magnetic elements (representing plastic stiffeners with magnetophores applied to them).

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	04823097717189	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): 84-89
Device Size Text, specify			Corset length (cm): 91-95