TM "Rehabilitimed" BR-1 XL Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" BR-1 XL Comfort
• Primary DI: 04823097723708
• Version / Model: BR-1 XL Comfort
• Catalog Number: BR-1 XL Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-19
• Public Version: 1
• Public Version Date: 2025-06-27
• Public Version Status: New
• Public Device Record Key: 7ae0fcd1-c5b2-4c66-932c-af352dea3d25

Device Description

It is a graphite colored chest bandage. The part of the bandage that fits to the back is made of elastic fabric, and the front-side parts are made of rich ball material (a special velor tri-laminated fabric (glued in a special way with polyurethane foam) with a rich terry cloth, complete with 2 plastic ribs.

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
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33031	Lumbar spine orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097723708	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			Thorax circumference (cm): 102-110
Device Size Text, specify			Thorax circumference (inch): 40,5-43