AccessGUDID - DEVICE: TM "Rehabilitimed" K-1-PSH L-XL Comfort (04823097723067)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04823097723067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: Detachable knee brace in graphite color, provides external semi-rigid fixation of the knee joint, relieves the capsular ligament apparatus and stabilizes the patella. Equipped with two lateral biomechanical hinged stiffening ribs and a silicone ring sewn inside the bandage to stabilize the patella in an anatomically correct position. Made of aeroprene (aeroprene is a soft, breathable highly elastic neoprene that has additional perforations that enhance air and moisture exchange) and multilayer material with a cotton layer against the body.

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
ITQ	Joint, Knee, 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: Mid-knee circumference in standing position (inch): 15-17,5

Device Record Status

Public Device Record Key: cebe033b-ebaf-45b1-8eea-05ef859eb0a5
Public Version Date: May 26, 2025
Public Version Number: 1
DI Record Publish Date: May 17, 2025