Identity
- Trade Name
- TM "Rehabilitimed" TUTOR-6K-VU UNI Left FDA UDI
- Generic Name
- Wrist/hand orthosis FDA UDI
- Device Name
- It is a wrist and thumb joint fixator, black. Made of elastic, breathable material, effectively maintains the temperature balance of the skin. Reinforced with two metal profiled tires that completely limit movement in the thumb and wrist joints. Tightening straps with textile fasteners on the forearm and thumb fix in the optimal position and support the tendons of the flexors and extensors of the hand. FDA UDI
- Model / Reference
- TUTOR-6K-VU UNI Left FDA UDI
- Description
- It is a wrist and thumb joint fixator, black. Made of elastic, breathable material, effectively maintains the temperature balance of the skin. Reinforced with two metal profiled tires that completely limit movement in the thumb and wrist joints. Tightening straps with textile fasteners on the forearm and thumb fix in the optimal position and support the tendons of the flexors and extensors of the hand. FDA UDI
Identifiers
- Catalog Number
- TUTOR-6K-VU UNI Left FDA UDI
- Primary DI / UDI-DI
- 04823097708439 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- Wrist/hand 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: Wrist/hand orthosis
TM "Rehabilitimed" TUTOR-6K-VU UNI Left 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 68e62e3c-60f8-4ee9-80b2-1b68a964cf4c 35 fields · synced May 31, 2026