Identity
- Trade Name
- TM "Rehabilitimed" TUTOR-3N UNI-3 Comfort FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- It is a three-panel knee brace, graphite in color. It consists of three parts made of modern multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth). The system of straps with textile Velcro fasteners ensures proper fit of the product to the body and more effective stabilization of the limb. The brace is reinforced with 5 rigid tires with an independent fastening system to the brace. FDA UDI
- Model / Reference
- TUTOR-3N UNI-3 Comfort FDA UDI
- Description
- It is a three-panel knee brace, graphite in color. It consists of three parts made of modern multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth). The system of straps with textile Velcro fasteners ensures proper fit of the product to the body and more effective stabilization of the limb. The brace is reinforced with 5 rigid tires with an independent fastening system to the brace. FDA UDI
Identifiers
- Catalog Number
- TUTOR-3N UNI-3 Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097719640 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-3N UNI-3 Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee support orthosis.
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- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- NON FRANCHISE — DJO, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Gripper Hinged Knee — MEDICAL SPECIALTIES INCORPORATED · Class I
- 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 50319a0b-b2d6-459b-a68e-5e8ca059a8ae 36 fields · synced May 31, 2026