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…
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.
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
Record
Regulatory record for Easymix® vacuum pump I | Listed by | Osartis Gmbh, Germany |
| FDA product code | JDY |
| Device type | Evacuator, Vapor, Cement Monomer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4220 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.