AccessGUDID - DEVICE: M-Brace Air (05391512281922)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 139 R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 139
Company Name: INDACO SRL

Primary DI Number: 05391512281922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: This Epicondylitis Brace (Tennis / Golfers Elbow brace) has been designed and produced as a support and protective device for tendon and joint inflammations either caused by trauma, stress or excessive fatigue. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to the specific construction, this brace can be worn and positioned very easily. The tension should be adjusted taking care not to slow down the normal circulation of blood. The pressure of the inside pad, which needs to be positioned immediately below the insertion of the tendon, relieves pain by diminishing the stress on muscles, tendons and 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?
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
IQI	Orthosis, Limb 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: 1ce97d19-614f-4c13-aac1-63689fa0e471
Public Version Date: February 20, 2024
Public Version Number: 1
DI Record Publish Date: February 12, 2024