Identity
- Trade Name
- TM "Rehabilitimed" TUTOR-6K-VU UNI Left FDA UDI
- Generic Name
- Wrist/hand orthosis FDA UDI
- Device Name
- Black wrist-hand orthosis, designed for complete fixation of the radiocarpal joint and thumb, provides external semi-rigid dosed fixation of the distal third of the forearm and radiocarpal joint, and the thumb in the abduction position. Reinforced with two metal profiled splints, one at an angle of 60 degrees to the hand relative to the forearm, located along the palm, the second at an angle of 0 degrees to the thumb in the abduction position. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
- Model / Reference
- TUTOR-6K-VU UNI Left FDA UDI
- Description
- Black wrist-hand orthosis, designed for complete fixation of the radiocarpal joint and thumb, provides external semi-rigid dosed fixation of the distal third of the forearm and radiocarpal joint, and the thumb in the abduction position. Reinforced with two metal profiled splints, one at an angle of 60 degrees to the hand relative to the forearm, located along the palm, the second at an angle of 0 degrees to the thumb in the abduction position. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
Identifiers
- Catalog Number
- TUTOR-6K-VU UNI Left FDA UDI
- Primary DI / UDI-DI
- 04823097722787 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
A comprehensive medical device directory entry for the TM 'Rehabilitimed' TUTOR-6K-VU UNI Left 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 760768df-c1c0-4f2e-be7c-ef45df013400 36 fields · synced Oct 6, 2026