AccessGUDID - DEVICE: TM "Rehabilitimed" GS-2 XL Comfort (04823097716892)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Rehabilitimed" GS-2 XL Comfort
Version or Model: GS-2 XL Comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GS-2 XL Comfort
Company Name: REABILITIMED TOV

Primary DI Number: 04823097716892
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: It is a fabric shoe, without a toe and heel, made of a multilayer material with a high cotton content. Reinforced on the sides with four metal stiffening ribs, curved to the shape of the leg and covered with a special material for a comfortable fit of the orthosis to the bone protrusions of the joint. The orthosis is attached to the leg by textile fasteners, which allow you to adjust the pressure on the fabric and position the product on the leg with maximum comfort. Graphite color.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITW	Joint, Ankle, External Brace

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Circumference above ankle bone (cm): 26-28

Device Record Status

Public Device Record Key: 0fcce8cf-58b5-446c-92c5-07d9d8d017f5
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 03, 2025