Identity
- Trade Name
- TM "Rehabilitimed" TUTOR-7K UNI Left Comfort FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- It is an Orthosis for the left hand, graphite color. Made of modern multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton knitted fabric) and reinforced with a rigid wide profiled splint with an angle of 60 degrees to the hand relative to the forearm, located along the palm. It can be used instead of a plaster splint. FDA UDI
- Model / Reference
- TUTOR-7K UNI Left Comfort FDA UDI
- Description
- It is an Orthosis for the left hand, graphite color. Made of modern multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton knitted fabric) and reinforced with a rigid wide profiled splint with an angle of 60 degrees to the hand relative to the forearm, located along the palm. It can be used instead of a plaster splint. FDA UDI
Identifiers
- Catalog Number
- TUTOR-7K UNI Left Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097719022 FDA UDI
- FDA Product Code
- ITM FDA UDI
- GMDN Term
- Knee support 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: Knee support orthosis
TM "Rehabilitimed" TUTOR-7K UNI Left Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Knee support orthosis.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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- DeRoyal — DEROYAL INDUSTRIES, INC. · 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
- Reabilitimed Tov
Sources (1)
- FDA UDI 3e7b8dfd-43d5-4a94-a1d3-2aff3d9dfccc 36 fields · synced May 30, 2026