AccessGUDID - DEVICE: M-Brace Air (05391512281021)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 576 S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 576
Company Name: INDACO SRL

Primary DI Number: 05391512281021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: Made of an elastic fabric, the CLAVICLE SUPPORT is comfortable and easy to put on. It is composed of two bands to be worn on the right and left shoulder, crossed behind the back and then locked together on the abdomen at the desired tightness. The constant support of the shoulders relaxes the pectoral muscles and improves posture. To ensure maximum comfort especially during extended use, this product was made with a breathable fabric. INDICATIONS • Rigid or falling shoulders • Bad posture • Clavicle injuries

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?
13810	Clavicle orthosis	A prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It incorporates padded straps that loop over each shoulder, under each arm, and around the back (e.g., figure-of-eight harness). This device may also be used to improve the patient's posture. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJB	Orthosis, Truncal, For Dysmenorrhea

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: 0427221a-560f-4616-b087-107af1b1f212
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: February 15, 2024