Fiberoptics Technology Inc
Fiber Optic Medical Light Guide 3.5mm
6manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1), Anhui (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 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Shenzhen Shanglaite Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Remanufacturer | 4 |
Record
| Listed by | Fiberoptics Technology, Inc., United States |
|---|---|
| FDA product code | EQH |
| Device type | Source, Carrier, Fiberoptic Light |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4350 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-04-20 |
| Record revised | 2021-01-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Fiber Optic Medical Light Guide | In distribution | |
| FTIMG 3.5mm | In distribution | |
| FTIMG 5mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 216 |
| Jedmed | Jedmed Instrument Company | 80 |
| Millennium | Avalign Technologies, Inc. | 72 |
| Ambler Surgical | Ambler Surgical, LLC | 40 |
| Elmed Incorporated | Elmed, Inc. | 36 |
| Fentex | Fentex medical GmbH | 36 |
| MicroFrance® | Integra Microfrance SAS | 24 |
| Elmed | Elmed, Inc. | 23 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 19 |
| Source, Carrier, Fiberoptic Light | Schölly Fiberoptic GmbH | 17 |
| BR Surgical, LLC | BR Surgical LLC | 16 |
| Bear | Mytamed, Inc. | 12 |
Showing 12 of 50. All products under Source, Carrier, Fiberoptic Light
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K904378 | 1991-01-16 |
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.