AccessGUDID - DEVICE: TM "Rehabilitimed" TUTOR-6K S Comfort (04823097719398)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04823097719398
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: It is an Orthosis for the hand bone, graphite color. Made of modern multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and 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 the left and right hand, it can be used instead of a plaster splint.

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 (cm): up to 17

Device Record Status

Public Device Record Key: 4c064c7c-b3d8-4e48-ac30-78e441b4d81e
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 04, 2025