AccessGUDID - DEVICE: TM "Rehabilitimed" DS-1 UNI Comfort (04823097716854)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Rehabilitimed" DS-1 UNI Comfort
Version or Model: DS-1 UNI Comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS-1 UNI Comfort
Company Name: REABILITIMED TOV

Primary DI Number: 04823097716854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: It has the appearance of an open structure in the form of a boot, to which a transverse crossbar is attached, which prevents rotation of the foot and the entire leg to the right, left, and additional fixing straps keep the foot from bending movements up and down. 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
No Device Sizes

Device Record Status

Public Device Record Key: be9bfa6b-ce51-4aaf-ab10-177419e61d76
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 03, 2025