Identity
- Trade Name
- EASYMIX® Nozzle slim 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 slim is shorter and of smaller diameter than the standard nozzle provided with the EASYMIX® vacuum mixing system. FDA UDI
- Model / Reference
- 02-0104 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 slim is shorter and of smaller diameter than the standard nozzle provided with the EASYMIX® vacuum mixing system. FDA UDI
Identifiers
- Catalog Number
- 02-0104 FDA UDI
- Primary DI / UDI-DI
- 04260056880612 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 — 8 Millimeter FDA UDILength — 173 Millimeter FDA UDI
Category: Orthopaedic cement preparation/delivery kit
EASYMIX® Nozzle slim by OSARTIS GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement preparation/delivery kit.
- PicoMix Syringe — G21 SRL · Class I
- MEDINAUT-Ix — IMEDICOM CO., LTD. · Class I
- Arthrex Bone Cement Mixing Syringe — G21 SRL · Class I
- Revolution — Stryker Corp. · Class I
- LITe BIO Delivery System — Stryker Corp. · Class II
- VORTEX — Smith & Nephew, Inc. · Class I
- StabiliT® — Merit Medical Systems, Inc. · Class II
- CEMEX SYSTEM FAST 70G — Tecres · Class II
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
- OSARTIS GmbH
Sources (1)
- FDA UDI 3feaf6c8-2580-426b-b81c-ba58995cb698 35 fields · synced Jun 6, 2026