Arthrex®
Synergy Matrix Management SW Addtnl Lic
11manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (3), Jiangsu (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Zhejiang Yigao Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | OUG |
| Device type | Medical Device Data System |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6310 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-16 |
| Record revised | 2024-03-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-3200-1036 | In distribution | |
| AR-3200-1044 | In distribution | |
| AR-3200-1043 | In distribution | |
| AR-3200-1049 | In distribution | |
| AR-3200-1045 | In distribution | |
| AR-3200-1046 | In distribution | |
| AR-3200-1026 | In distribution | |
| AR-3200-1034 | In distribution | |
| AR-3200-1052 | In distribution | |
| AR-3200-1040 | In distribution | |
| AR-3200-1030 | In distribution | |
| AR-3200-1020 | In distribution | |
| AR-3200-1047 | In distribution | |
| AR-3200-1053 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Responder | Rauland-Borg Corporation | 170 |
| Medical Device Data System | Pentax of America, Inc. | 72 |
| DreamStation | Respironics Inc. | 55 |
| Endopro IQ | Pentax of America, Inc. | 49 |
| MonitAir | Monitair, LLC | 22 |
| Medical Device Data System | Medtronic, Inc. | 20 |
| DreamMapper | Respironics Inc. | 16 |
| Visionflex | Visionflex PTY Limited | 11 |
| Intesys Clinical Suite | Spacelabs Healthcare (Washington), Inc | 11 |
| myoncare | Oncare GmbH | 9 |
| MicroScan | Beckman Coulter, Inc. | 9 |
| Broadband | Respironics Inc. | 8 |
Showing 12 of 281. All products under Medical Device Data System
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.