Identity
- Trade Name
- TM "Rehabilitimed" TUTOR-3N UNI-1 Comfort FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- Detachable knee brace, graphite color, provides external semi-rigid fixation of the knee joint in the extension position from the middle third of the thigh to the middle third of the shin, which eliminates the possibility of movements in the knee joint. Reinforced with 5 rigid tires with a system of independent fastening to the side surfaces of the brace and a system of six straps equipped with textile fasteners that ensure proper fit of the product to the body. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
- Model / Reference
- TUTOR-3N UNI-1 Comfort FDA UDI
- Description
- Detachable knee brace, graphite color, provides external semi-rigid fixation of the knee joint in the extension position from the middle third of the thigh to the middle third of the shin, which eliminates the possibility of movements in the knee joint. Reinforced with 5 rigid tires with a system of independent fastening to the side surfaces of the brace and a system of six straps equipped with textile fasteners that ensure proper fit of the product to the body. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
Identifiers
- Catalog Number
- TUTOR-3N UNI-1 Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097723227 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-1 Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee support orthosis.
- VQ ORTHOCARE — Vision Quest Industries Incorporated · Class I
- MECRON Knee Flexion 10deg L:500mm, OS:590mm, US:380mm — Darco (Europe) GmbH · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reabilitimed Tov
Sources (1)
- FDA UDI cbdff43c-71a5-472d-b525-bd22ac9e0ccc 36 fields · synced May 30, 2026