Identity
- Trade Name
- EASYMIX® vacuum pump II FDA UDI
- Generic Name
- Orthopaedic material preparation vacuum pump FDA UDI
- Device Name
- The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room. The EASYMIX® II vacuum pump is equipped with an indicator for functionality. FDA UDI
- Model / Reference
- 02-0201 FDA UDI
- Description
- The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room. The EASYMIX® II vacuum pump is equipped with an indicator for functionality. FDA UDI
Identifiers
- Catalog Number
- 02-0201 FDA UDI
- Primary DI / UDI-DI
- 04260056881930 FDA UDI
- FDA Product Code
- JDY FDA UDI
- GMDN Term
- Orthopaedic material preparation vacuum pump FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic material preparation vacuum pump
EASYMIX® vacuum pump II by OSARTIS GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic material preparation vacuum pump.
- PALAMIX® — Heraeus Medical LLC · Class I
- EASYMIX® vacuum pump I — OSARTIS GmbH · 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
- OSARTIS GmbH
Sources (1)
- FDA UDI ab0826bf-7ba5-4b46-9abe-0a42bf158a90 34 fields · synced May 30, 2026