Evacuator, Vapor, Cement Monomer
5 catalogue numbers from 00-5049-086-00, listed by Zimmer Orthopaedic Surgical Products, United States, under Evacuator, Vapor, Cement Monomer. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | Zimmer Orthopaedic Surgical Products, United States |
|---|---|
| FDA product code | JDY |
| Device type | Evacuator, Vapor, Cement Monomer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4220 |
| Premarket notification | Exempt |
| Record published | 2019-03-08 |
| Record revised | 2021-02-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5049-086-00 | In distribution | |
| 00-5049-087-00 | In distribution | |
| 00-5049-089-00 | In distribution | |
| 00-5049-088-00 | In distribution | |
| 00-5049-085-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Easymix® compressed air hose | Osartis Gmbh | 2 |
| HNM Medical | HNM Stainless, LLC. | 2 |
| SmartMix Vacuum Footpump and Airhose | Summit Medical LLC | 1 |
| Palamix® | Heraeus 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.