Hayden Medical
Endoscopic Camera System and Light Source, Full HD 1080P Resolution with white balancing, zoom, and image capture. 2.3 Pro Camera head, 11 surgery modes, improved color, stroboscopic…
Endoscopic Camera System and Light Source, Full HD 1080P Resolution with white balancing, zoom, and image capture. 2.3 Pro Camera head, 11 surgery modes, improved color, stroboscopic surgery Includes: Camera Head, Fiber Optic Light Cable
Who Else Makes It
Concentrated in Anhui (2), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | Hayden Medical Inc, United States |
|---|---|
| FDA product code | FWF |
| Device type | Camera, Television, Endoscopic, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2025-04-30 |
| Record revised | 2026-04-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2026-04-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 405-465CS | In distribution | |
| 405-465 | In distribution | |
| 405-463CS | In distribution | |
| 405-470 | In distribution | |
| 405-463 | In distribution | |
| 405-465CS | Withdrawn | |
| 405-470 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Camera, Television, Endoscopic, Without Audio | Smith & Nephew, Inc. | 30 |
| C-Camsource® | Joimax Gmbh | 10 |
| Fibre optic cable adpater | Joimax Gmbh | 6 |
| Camsource® | Joimax Gmbh | 6 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 5 |
| Camera, Television, Endoscopic, Without Audio | Pentax of America, Inc. | 4 |
| D-Camsource® | Joimax Gmbh | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Camera, Television, Endoscopic, Without Audio | Karl Storz GmbH & Co. KG | 3 |
| Camera, Television, Endoscopic, Without Audio | Medos International Sàrl | 3 |
| Camera, Television, Endoscopic, Without Audio | Schölly Fiberoptic GmbH | 3 |
| Procam HD Basic | Ecleris SRL | 3 |
Showing 12 of 33. All products under Camera, Television, Endoscopic, Without Audio
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.