AccessGUDID - DEVICE: M-Brace Air (05391512282059)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 136 LE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 136
Company Name: INDACO SRL

Primary DI Number: 05391512282059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: This Wrist Splint has been designed and produced as a support and protective device for muscular damages, as well as for tendon and joint injuries either caused by trauma, stress or excessive fatigue. Available in right or left for a perfect fit and superior comfort. 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 this specific construction, a vast range of closing positions are available, depending on the tension desired. The two aluminum stays, pre-shaped and moldable for custom fitting, can be removed according to the need of immobilization of the patient.

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?
41459	Wrist/hand orthosis	An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILH	Splint, Hand, And Components

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: 98e71040-1ba4-4bc1-b646-376a51de6e60
Public Version Date: February 22, 2024
Public Version Number: 1
DI Record Publish Date: February 14, 2024