Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- This product is an accessory to our back braces. It is an extender. It can be added to our back braces to offer better range support, improved fit and larger size. It is made with the same natural materials as all our products. Velcro acts as the adhesive to connect the product. FDA UDI
- Model / Reference
- A84E FDA UDI
- Description
- This product is an accessory to our back braces. It is an extender. It can be added to our back braces to offer better range support, improved fit and larger size. It is made with the same natural materials as all our products. Velcro acts as the adhesive to connect the product. FDA UDI
Identifiers
- Catalog Number
- A84E FDA UDI
- Primary DI / UDI-DI
- 05391512282417 FDA UDI
- FDA Product Code
- IQE FDA UDI
- GMDN Term
- Lumbar spine orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
Yes
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: Lumbar spine orthosis
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 62a83e2f-08c9-4447-b4bb-e41c38bccab1 35 fields · synced May 30, 2026