Imager Adaptor for Stryker Niagra® Retractor
Imager Adaptor for Stryker Niagra® Retractor, 5-pk Carton
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Chengdu Corder Optics & Electronics Co., Ltd. | Chengdu | Sichuan | Manufacturer | 1 |
| Hefei MAX ACT Medical Equipment Co., Ltd. | Hefei | Anhui | Manufacturer | 1 |
| Shanghai Eder Medical Technology Inc. | Shanghai | Shanghai | Manufacturer | 1 |
| Suzhou Semorr Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Viseon, Inc., United States |
|---|---|
| FDA product code | FSO |
| Device type | Microscope, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SKN-S | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 130 |
| MaxView System – Lateral Set | Viseon, Inc. | 7 |
| S100 / Opmi pico | Carl Zeiss Meditec Inc | 6 |
| S7 / Opmi PROergo | Carl Zeiss Meditec Inc | 6 |
| Aesculap | Aesculap AG | 4 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 4 |
| MaxView™ System – Lateral Set with Illumination | Viseon, Inc. | 3 |
| S7 / Opmi Sensera | Carl Zeiss Meditec Inc | 3 |
| Medical Microscope | Denjoy Dental Co., Ltd. | 3 |
| RoboticScope | Bhs Intl., Inc. | 2 |
| Rols Reinverter – Leica+ | Volk Optical Inc. | 2 |
| Rols Reinverter – Zeiss + | Volk Optical Inc. | 2 |
Showing 12 of 130. All products under Microscope, Surgical, General & Plastic Surgery
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.