AccessGUDID - DEVICE: TM "Rehabilitimed" K-1TM XL Comfort (04823097721506)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04823097721506
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: The orthopedic device is graphite in color, has a dense structure, is an elastic circular knee joint orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforation holes on the entire surface that improve air and moisture exchange) with an insert made of a special mesh fabric under the knee, equipped with a relief limiting silicone ring around the hole for the patella, reinforced with two flexible spring stiffening ribs on the side surfaces and additional fixing straps.

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: Mid-knee circumference in standing position (cm): 42-45

Device Record Status

Public Device Record Key: f7a47776-18ae-4856-8d06-39dfab98af89
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 04, 2025