Identity
- Trade Name
- TM "Rehabilitimed" RS-B12 XL Comfort FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- It is a knitted ankle bandage, article number RS-B12, graphite color, with a turquoise pattern. Made of nylon and elastane, reinforced with silicone inserts. FDA UDI
- Model / Reference
- RS-B12 XL Comfort FDA UDI
- Description
- It is a knitted ankle bandage, article number RS-B12, graphite color, with a turquoise pattern. Made of nylon and elastane, reinforced with silicone inserts. FDA UDI
Identifiers
- Catalog Number
- RS-B12 XL Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097716458 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Ankle/foot 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
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: Ankle/foot orthosis
TM "Rehabilitimed" RS-B12 XL Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 664c6037-89bb-4adb-a940-3cc4732cc393 36 fields · synced May 30, 2026