M-Brace Air

Basic Information

• Brand Name: M-Brace Air
• Primary DI: 05391512282240
• Version / Model: 0T6 Left
• Catalog Number: Hernia Pad
• Company Name: INDACO SRL
• Labeler DUNS: 338470646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-23
• Public Version: 1
• Public Version Date: 2024-03-04
• Public Version Status: New
• Public Device Record Key: e792c454-0d7a-490b-9945-f280e8496db4

Device Description

Our Hernia pads are available in Left and Right. Product details: 100% Cotton on the skin, Washable, Breathable, Non-Allergenic, Grey color They are included in our Hernia Support Brief Products # 610, 609, 648, 655, 672. They can be purchased separately if needed.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• 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
Primary	05391512282240	GS1

Customer Contacts

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