TM "Rehabilitimed" GS-2 S Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" GS-2 S Comfort
• Primary DI: 04823097722619
• Version / Model: GS-2 S Comfort
• Catalog Number: GS-2 S Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-17
• Public Version: 1
• Public Version Date: 2025-05-26
• Public Version Status: New
• Public Device Record Key: 5afae02d-4e51-4e5f-aa08-0f9c23a9aedf

Device Description

The graphite-colored ankle-foot orthosis provides external semi-rigid fixation. The detachable orthosis is reinforced on the sides with four metal stiffening ribs, curved according to anatomical shapes and covered with a special material for a comfortable fit to the bone protrusions of the joint. Convenient fastening on the leg is carried out due to textile fasteners. Made of multilayer material with a cotton layer to the body and polyamide on the outside.

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
ITW	Joint, Ankle, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36206	Ankle/foot orthosis	A prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097722619	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			Circumference above ankle bone (inch): 6,5-7,5