AccessGUDID - DEVICE: TM "Rehabilitimed" RP-6K-M1 XXL Comfort (04823097719442)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Rehabilitimed" RP-6K-M1 XXL Comfort
Version or Model: RP-6K-M1 XXL Comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RP-6K-M1 XXL Comfort
Company Name: REABILITIMED TOV

Primary DI Number: 04823097719442
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 shoulder and elbow joint, beige in color. Made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and designed so that the two sleeves supporting the arm are easily adjusted in height using a textile fastener. Additionally equipped with a belt around the chest to press the arm to the body for its reliable fixation.

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?
41053	Elbow orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOY	Support, Arm

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: Chest circumference with hand pressed (cm): > 100

Device Record Status

Public Device Record Key: 21e62771-481f-4ae0-a8e4-e960fa3292b1
Public Version Date: May 12, 2025
Public Version Number: 1
DI Record Publish Date: May 04, 2025