Accu-Beam
22.5mm-50mm parfocal Zoom Endoscopic Coupler. Insulated.
6manufacturers in China registered for this device type
10catalogue numbers in this listing
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd | Beijing | Beijing | Contract manufacturer | 5 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
| Xuzhou Hengjia Electronic Technology Co., Ltd. | Xuzhou | Jiangsu | Manufacturer | 2 |
| Shenzhen Tuyou Medical Imaging Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Xuzhou AKX Electronic Science and Technology Co., Ltd. | Xuzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Transamerican Technologies International, 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-29 |
| Record revised | 2021-10-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8009I | In distribution | |
| 8007I | In distribution | |
| 8020RF | In distribution | |
| 8008I | In distribution | |
| 8050 | In distribution | |
| 8019I | In distribution | |
| 8020I | In distribution | |
| 8051 | In distribution | |
| 8052 | In distribution | |
| 8013I | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hayden Medical | Hayden Medical Inc | 4 |
| mytaMed | Mytamed, Inc. | 4 |
| Duroscope | FMD. Co., Ltd. | 3 |
| Firefly | Firefly Global | 2 |
| ITS Model-L6K | Inthesmart Co., Ltd. | 1 |
| Prosidio | Prosidio LLC | 1 |
| UnivLabs | Univlabs Technologies Private Limited | 1 |
| Health Support | Carolon Co. | 1 |
| ITS Model-L | Inthesmart Co., Ltd. | 1 |
| Redfin | Firefly Global | 1 |
| FocESS | Stryker GmbH | 1 |
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.