Identity
- Trade Name
- EASYMIX® Nozzle revision FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle. The EASYMIX® Nozzle revision is longer and of larger diameter than the EASYMIX® standard nozzle. FDA UDI
- Model / Reference
- 02-0105 FDA UDI
- Description
- The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle. The EASYMIX® Nozzle revision is longer and of larger diameter than the EASYMIX® standard nozzle. FDA UDI
Identifiers
- Catalog Number
- 02-0105 FDA UDI
- Primary DI / UDI-DI
- 04260056880919 FDA UDI
- FDA Product Code
- JDZ FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 13 Millimeter FDA UDILength — 280 Millimeter FDA UDI
Category: Orthopaedic cement preparation/delivery kit
EASYMIX® Nozzle revision by OSARTIS GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement preparation/delivery kit.
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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
- OSARTIS GmbH
Sources (1)
- FDA UDI a2e22e67-15dd-49e1-af1c-f91113270f8c 35 fields · synced May 30, 2026