Palamix®
Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacuum
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Heraeus Medical LLC, United States |
|---|---|
| FDA product code | JDY |
| Device type | Evacuator, Vapor, Cement Monomer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4220 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Vacuum Pump | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Evacuator, Vapor, Cement Monomer | Zimmer Orthopaedic Surgical Products | 5 |
| Easymix® compressed air hose | Osartis Gmbh | 2 |
| HNM Medical | HNM Stainless, LLC. | 2 |
| SmartMix Vacuum Footpump and Airhose | Summit Medical LLC | 1 |
| Easymix® vacuum pump I | Osartis Gmbh | 1 |
| Summit Medical High Vacuum Footpump + Air Hose | Summit Medical LLC | 1 |
| Easymix® vacuum pump II | Osartis Gmbh | 1 |
| SmartMix CemVac Dual Vacuum Footpump & Airhose | Summit Medical LLC | 1 |
| Miller™ | Zimmer, Inc. | 1 |
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.