Endoscopic Camera System and Light Source, 4K Resolution with white balancing, zoom, and image capture. 4K camera head. Includes: Camera Head, Fiber Optic Light Cable, footswitch, USB Drive…
Endoscopic Camera System and Light Source, 4K Resolution with white balancing, zoom, and image capture. 4K camera head. Includes: Camera Head, Fiber Optic Light Cable, footswitch, USB Drive and Power Cable
Who Else Makes It
Concentrated in Jiangsu (2), Anhui (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Hayden Medical | Listed by | Hayden Medical Inc, United States |
| FDA product code | FWL |
| Device type | Camera, Cine, Endoscopic, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-06-27 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
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.