AccessGUDID - DEVICE: M-Brace Air (05391512282677)

GUDID

Device Identifier (DI) Information

Brand Name: M-Brace Air
Version or Model: 609 XL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 609
Company Name: INDACO SRL

Primary DI Number: 05391512282677
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338470646 *Terms of Use

Device Description: Hernia Support Post-Op HIGH Cut Brief. These hernia briefs exert a compression and support action on the abdomen to avoid that the tissues may yield and/or sag and to contain reducible inguinal hernias. In order to obtain the best functional results, a wide range of models offering a wide, comfortable and extremely flexible compression surface has been developed. Instead of pressing against the hernia, these briefs simply provide support to achieve better dynamic results: the support structures in the various models are shaped to run oblique compared to the waistband, which is lower in front and higher on the back. To avoid any excessive elastic forces, the materials used are marked by a cushioned return elastic force and a self-stabilizing action thanks to an exclusive system used in making this fabric. It is made of 100% cotton to provide the utmost hygiene, freshness and comfort. Some models have special interior pockets for the application of shaped anatomic hernia pads to exert a firmer support action on reducible inguinal hernias. These pads, too, are covered with a soft 100% cotton anatomic, self-shaping material. Indications: For inguinal hernias (designed for the use of extra pads) and post-operative treatment. Post-operative to prevent the sagging of abdominal tissues Support during sports and heavy work activities. Product Details Pads- Left and Right included 100% Cotton on the skin Washable Breathable Non-Allergenic High cut model Available in the color light Grey ONLY

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?
47218	Abdominal hernia truss, reusable	A device, typically in the form of a strap(s), designed to be worn over an abdominal hernia opening (weakness in the abdominal wall) to prevent protrusion of the abdominal contents and retain the reduced hernia within the abdominal cavity. It may be made from a variety or combination of various materials (e.g., elastic, canvas, or metallic). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXN	Support, Hernia

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: 95a117a2-e421-467c-9dc9-f1e584439d9f
Public Version Date: February 23, 2024
Public Version Number: 1
DI Record Publish Date: February 15, 2024