Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Abdominal binder, reusable FDA UDI
- Device Name
- This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment FDA UDI
- Model / Reference
- 515 M FDA UDI
- Description
- This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment FDA UDI
Identifiers
- Catalog Number
- 515 FDA UDI
- Primary DI / UDI-DI
- 05391512284305 FDA UDI
- FDA Product Code
- FSD FDA UDI
- GMDN Term
- Abdominal binder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5160 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 binder, reusable
M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Indaco Srl
Sources (1)
- FDA UDI e632efc2-37a1-4f27-b1f7-4b2a93d99ece 35 fields · synced May 30, 2026