System, X-Ray, Angiographic
Endoscope, Firefly
7manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Beijing (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Intuitive Surgical, Inc., United States |
|---|---|
| FDA product code | IZI |
| Device type | System, X-Ray, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1600 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-07-08 |
| Record revised | 2023-10-20 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Peracetic Acid, Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Angle 0 to 30 °; outer diameter 8.5 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 370893 | Angle 30 ° | In distribution |
| 370892 | Outer Diameter 12 mm | In distribution |
| 372010 | Outer Diameter 8.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterimed | Sterimed, Inc. | 114 |
| Med-Syringe | Argon Medical Devices, Inc. | 16 |
| Control Syringe | Argon Medical Devices, Inc. | 14 |
| Novadaq and Pinpoint | Novadaq Technologies, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Namic | Navilyst Medical, Inc. | 9 |
| Namic | Medline Industries, Inc. | 8 |
| iMRX System | Imris Imaging, Inc. | 6 |
| System, X-Ray, Angiographic | B. Braun Medical Inc. | 4 |
| Leica FL800 | Leica Microsystems (Schweiz) AG | 3 |
| Infrared 800 with Flow® 800 Option | Carl Zeiss Meditec Inc | 2 |
| Leica FL800 ULT | Leica Microsystems (Schweiz) AG | 2 |
Showing 12 of 51. All products under System, X-Ray, Angiographic
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.