Identity
- Trade Name
- TM "Rehabilitimed" L-4M-3 S Comfort FDA UDI
- Generic Name
- Multiple spinal region orthosis FDA UDI
- Device Name
- Orthopedic device of graphite color, for the lumbar and sacral spine, medium degree of fixation with metal stiffeners allows to achieve a high stabilizing effect by providing external semi-rigid fixation, made of elastic multilayer material (cotton twill tripled fabric (glued in a special way with polyurethane foam) with gabardine fabric), which ensures the stability of the location of 4 powerful modeled duralumin stiffeners. Complete with a set of magnetic elements (representing plastic stiffeners with magnetophores applied to them). FDA UDI
- Model / Reference
- L-4M-3 S Comfort FDA UDI
- Description
- Orthopedic device of graphite color, for the lumbar and sacral spine, medium degree of fixation with metal stiffeners allows to achieve a high stabilizing effect by providing external semi-rigid fixation, made of elastic multilayer material (cotton twill tripled fabric (glued in a special way with polyurethane foam) with gabardine fabric), which ensures the stability of the location of 4 powerful modeled duralumin stiffeners. Complete with a set of magnetic elements (representing plastic stiffeners with magnetophores applied to them). FDA UDI
Identifiers
- Catalog Number
- L-4M-3 S Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097717134 FDA UDI
- FDA Product Code
- MRI FDA UDI
- GMDN Term
- Multiple spinal region 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple spinal region orthosis
TM "Rehabilitimed" L-4M-3 S Comfort by Reabilitimed Tov — 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
- Reabilitimed Tov
Sources (1)
- FDA UDI 1b6c5a93-a00a-4a91-8be0-bdf1482835b1 36 fields · synced May 31, 2026