AccessGUDID - DEVICE: TM "Rehabilitimed" TUTOR-6K-V XL Comfort (04823097722770)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Rehabilitimed" TUTOR-6K-V XL Comfort
Version or Model: TUTOR-6K-V XL Comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TUTOR-6K-V XL Comfort
Company Name: REABILITIMED TOV

Primary DI Number: 04823097722770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: Wrist-hand orthosis in graphite color, provides external semi-rigid dosed fixation of the carpal joint to the lower third of the forearm. Reinforced with a rigid wide profiled splint with an angle of 60 degrees to the hand relative to the forearm, located along the palm. Universal for left and right hands. Made of multilayer material with a cotton layer to the body and polyamide on the outside.

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?
41065	Knee support orthosis	A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITM	Cage, Knee

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: Wrist circumference (inch): more than 8,5

Device Record Status

Public Device Record Key: cc5be9d0-5561-4208-b694-5c9b60ebadd5
Public Version Date: May 26, 2025
Public Version Number: 1
DI Record Publish Date: May 17, 2025