DJO Surgical
Optivac MAX Capacity Total HIP KIT (High VOL Cement)
14manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Hebei (2), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
Showing 12 of 14. All 14 manufacturers in China registered for Mixer, Cement, For Clinical Use
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | JDZ |
| Device type | Mixer, Cement, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4210 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-01-21 |
| Record revised | 2021-06-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600-99-003 | In distribution | |
| 600-30-020 | In distribution | |
| 60060004-01 | In distribution | |
| 600-60-005 | In distribution | |
| 600-60-003 | In distribution | |
| 600-70-040 | In distribution | |
| 600-99-001 | In distribution | |
| 60060004-03 | In distribution | |
| 600-99-004 | In distribution | |
| 60060004 | In distribution | |
| 600-50-080 | In distribution | |
| 60060005-02 | In distribution | |
| 60060004-04 | In distribution | |
| 600-50-120 | In distribution | |
| 600-70-010 | In distribution | |
| 60060005-01 | In distribution | |
| 600-70-050 | In distribution | |
| 60060003-01 | In distribution | |
| 600-50-040 | In distribution | |
| 60060004-02 | In distribution | |
| 600-60-004 | In distribution | |
| 600-70-030 | In distribution | |
| 600-99-002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 26 |
| Mixer, Cement, For Clinical Use | Stryker GmbH | 22 |
| Revolution | Stryker GmbH | 17 |
| Cleanest | Guangzhou Clean Medical Products Manufacturing Corp | 15 |
| Midway Select | Midway Dental Supply, LLC | 8 |
| Mixor | Smith & Nephew, Inc. | 7 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 6 |
| Mini-Bowls | Pulpdent Corporation | 4 |
| AutoPlex, VertaPlex | Stryker GmbH | 4 |
| Quick-Vac® Vacuum Mixing Bowl | Summit Medical LLC | 4 |
| Henry Schein | Henry Schein, Inc. | 3 |
| PicoMix Syringe | G21 SRL | 3 |
Showing 12 of 84. All products under Mixer, Cement, For Clinical Use
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.