AccessGUDID - DEVICE: M-Brace Air (05391512280109)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 45
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 45
Company Name: INDACO SRL

Primary DI Number: 05391512280109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: The Jumper’s Knee Brace been designed and produced as a support and protective device for tendon and joint inflammations either cause by trauma, stress or excessive fatigue. INDICATIONS : • Apophysitis, patellar chondromalacia, patellofemoral anthralgia, jumper’s knee. • Alleviates pain by diminishing tension on muscles and ligaments. • Could be used as a preventive measure during sports or in a rehab phase. • Swiftly adjustable compression. • 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):	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
FQM	Bandage, Elastic

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: 3c6bb06f-b7c5-4164-8776-d9bb1e8979fa
Public Version Date: February 21, 2024
Public Version Number: 1
DI Record Publish Date: February 13, 2024