Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Ankle binder, reusable FDA UDI
- Device Name
- The Mercurio Ankle Lock brace, with elastic, reinforced strap to be applied to the ankle using our locking system. In order to ensure maximum comfort and tolerance, especially in the case of extended use, particular care and attention have been dedicated to the selection of materials and fabrics. As such, our products are made exclusively with all natural, hypo-allergenic and breathable fibers. The inside fabric of this product is the result of a unique technology. It is made with very soft cotton velour providing the skin with an extremely comfortable touch and at the same time, allowing it to breathe freely all day-even while playing sports. FDA UDI
- Model / Reference
- 15 R FDA UDI
- Description
- The Mercurio Ankle Lock brace, with elastic, reinforced strap to be applied to the ankle using our locking system. In order to ensure maximum comfort and tolerance, especially in the case of extended use, particular care and attention have been dedicated to the selection of materials and fabrics. As such, our products are made exclusively with all natural, hypo-allergenic and breathable fibers. The inside fabric of this product is the result of a unique technology. It is made with very soft cotton velour providing the skin with an extremely comfortable touch and at the same time, allowing it to breathe freely all day-even while playing sports. FDA UDI
Identifiers
- Catalog Number
- 15 FDA UDI
- Primary DI / UDI-DI
- 05391512280123 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Ankle binder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 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
No
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: Ankle 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 03c7aac4-8922-401d-b9d3-8d5d65b56059 35 fields · synced May 31, 2026