AccessGUDID - DEVICE: M-Brace Air (05391512280321)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 40 XXL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40
Company Name: INDACO SRL

Primary DI Number: 05391512280321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: Vega Patella Stabilizer Knee brace is for both right and left knees providing optimal support and protection following muscle, joint or tendon injuries in the region of the patella. Constructed exclusively from breathable hypoallergenic fabrics (Neoprene-free and Latex-free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in three different areas. Featuring two unique C-shaped pressure pads which, when brought together as the brace is secured, surround and stabilize the patella. 2 low profile 2 mm super light rods, to keep the brace in place 2 replacement super light rods (for product 40 only) 2 multi-centric molded aluminum hinges (LATERAL and MEDIAL, product 41 only) for improved lateral support in cases of patella related pathologies associated with minor instability of medial and/or lateral collateral ligaments.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: 0b4b0d18-f1dc-4bdd-a7df-1d3bcdc5ee05
Public Version Date: February 21, 2024
Public Version Number: 1
DI Record Publish Date: February 13, 2024