M-Brace Air

Basic Information

• Brand Name: M-Brace Air
• Primary DI: 05391512282677
• Version / Model: 609 XL
• Catalog Number: 609
• Company Name: INDACO SRL
• Labeler DUNS: 338470646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-15
• Public Version: 1
• Public Version Date: 2024-02-23
• Public Version Status: New
• Public Device Record Key: 95a117a2-e421-467c-9dc9-f1e584439d9f

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXN	Support, Hernia	Gastroenterology, Urology	876.5970	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391512287092	GS1	Box Case	10	In Commercial Distribution
Primary	05391512282677	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]