AccessGUDID - DEVICE: M-Brace Air (05391512280468)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 75 L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 75
Company Name: INDACO SRL

Primary DI Number: 05391512280468
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: The Knee Brace # 75 Artemis Light MCL-LCL Instability is for both right and left knees providing optimal support and protection following muscle, joint and/or tendon injuries, LCL MCL weakness. It is constructed exclusively from breathable hypoallergenic fabrics (neoprene 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 two different areas - 2 molded aluminum hinges (lateral and medial) for optimal lateral support- 2 low profile 2mm super light rods, to keep the brace in place during compression therapy. Indications ° Traumatic pathologies: light distortions, light articular laxity, bursitis, articular effusion. ° Rehab phase: passive support during rehab, light protection during sports. ° Offers compression and slight re- alignment in the presence of mild osteorthratis ° Anatomically shaped medial and lateral aluminum polycentric hinges guarantee a complete synchrony with the natural movement of the knee. ° Breathable, 100% cotton on your skin.

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):	Yes
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: b442d64d-3cbc-4b5e-8d6a-0bb894a8e5ba
Public Version Date: February 21, 2024
Public Version Number: 1
DI Record Publish Date: February 13, 2024