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M-Brace Air

FDA UDI

Class I (US FDA UDI)

by Indaco Srl

Identity

Trade Name
M-Brace Air FDA UDI
Generic Name
Abdominal hernia truss, reusable FDA UDI
Device Name
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 FDA UDI
Model / Reference
609 XL FDA UDI
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 FDA UDI

Identifiers

Catalog Number
609 FDA UDI
Primary DI / UDI-DI
05391512282677 FDA UDI
FDA Product Code
EXN FDA UDI
GMDN Term
Abdominal hernia truss, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5970 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Abdominal hernia truss, reusable

M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Abdominal hernia truss, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Indaco Srl

Sources (1)

  • FDA UDI 95a117a2-e421-467c-9dc9-f1e584439d9f 35 fields · synced May 30, 2026