Identity
- Trade Name
- MECRON Knee 3-part 30deg FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- 50 cm Black FDA UDI
- Model / Reference
- OH655334 FDA UDI
- Description
- 50 cm Black FDA UDI
Identifiers
- Catalog Number
- OH655334 FDA UDI
- Primary DI / UDI-DI
- 00609271951860 FDA UDI
- FDA Product Code
- ITQ 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Knee support orthosis
The MECRON Knee 3-part 30deg is a stand-alone prefabricated orthopaedic appliance designed to support, align, prevent, or correct deformities/injuries or improve function of the knee. It may incorporate hinges for improved support and is not a component of a larger device assembly.
Similar devices
Also classified as Knee support orthosis.
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- NON FRANCHISE — DJO, LLC · 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
- Darco (Europe) GmbH
Sources (1)
- FDA UDI df534a1b-0320-44d3-94a0-cb8ce5abccff 34 fields · synced Jul 30, 2026