Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Wrist/hand/metacarpophalangeal joint extension orthosis FDA UDI
- Device Name
- The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief. FDA UDI
- Model / Reference
- 35 RE FDA UDI
- Description
- The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. • Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. • Rehab phase: provides post-trauma and post-op tendon muscle relief. FDA UDI
Identifiers
- Catalog Number
- 35 FDA UDI
- Primary DI / UDI-DI
- 05391512281328 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- Wrist/hand/metacarpophalangeal joint extension orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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: Wrist/hand/metacarpophalangeal joint extension orthosis
M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wrist/hand/metacarpophalangeal joint extension orthosis.
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- M-Brace Air — INDACO SRL · Class I
- M-Brace Air — INDACO SRL · Class I
- M-Brace Air — INDACO SRL · Class I
- M-Brace Air — INDACO SRL · Class I
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 d1f6bb2d-0895-4cc0-a1e5-0637da2ef961 35 fields · synced May 30, 2026