TM "Rehabilitimed" ORTEZ-2V-1 XL-110 Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" ORTEZ-2V-1 XL-110 Comfort
• Primary DI: 04823097719787
• Version / Model: ORTEZ-2V-1 XL-110 Comfort
• Catalog Number: ORTEZ-2V-1 XL-110 Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-04
• Public Version: 1
• Public Version Date: 2025-05-12
• Public Version Status: New
• Public Device Record Key: 536db00a-fec0-4e9d-9d13-daf60a4057f9

Device Description

It is an orthosis for the cervical spine in the form of an anatomically shaped base made of foamed polyethylene 110 mm high, which has the necessary density and elasticity, and a cover made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) of beige color. On both sides of the orthosis, a textile fastener is sewn, which allows you to more accurately fix the product around the neck.

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
IQK	Orthosis, Cervical	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45129	Cervical spine collar, single-use	A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097719787	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			Neck circumference (cm): 46-53
Device Size Text, specify			Orthosis height (mm): 110