Source, Carrier, Fiberoptic Light
Light Guide 3.5 x 3000 mm, HT version
6manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | Schölly Fiberoptic GmbH |
|---|---|
| FDA product code | EQH |
| Device type | Source, Carrier, Fiberoptic Light |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4350 |
| Premarket notification | Exempt |
| Record published | 2019-02-13 |
| Record revised | 2026-05-18 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 5 to 95 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 70 °C |
| Sizes | Length 1800 to 3000 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05.0085l | Diameter 3.5 mm | In distribution |
| 05.0087l | Diameter 4.8 mm | In distribution |
| 05-0094l-nir | Diameter 4.8 mm | In distribution |
| 05.0088l | Length 2300 mm | In distribution |
| 05.0087l | Diameter 4.8 mm | In distribution |
| 05.0085l.ht | Length 3000 mm | In distribution |
| 05-0094l-nir | Diameter 4.8 mm | In distribution |
| 05.0090l.ht | Length 2300 mm | In distribution |
| 05.0090l | Diameter 4.8 mm | In distribution |
| 05.0085l.ht | Length 3000 mm | In distribution |
| 05.0088l.ht | Diameter 3.5 mm | In distribution |
| 05.0084l | Diameter 3.5 mm | In distribution |
| 05.0088l.ht | Diameter 3.5 mm | In distribution |
| LG-7000X | Diameter 3.5 mm | In distribution |
| 05.0090l | Diameter 4.8 mm | In distribution |
| 05.0090l.ht | Length 2300 mm | In distribution |
| 05.0086l | Length 1800 mm | 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 |
| BR Surgical, LLC | BR Surgical LLC | 16 |
| Bear | Mytamed, Inc. | 12 |
| mytaMed | Mytamed, Inc. | 12 |
Showing 12 of 50. All products under Source, Carrier, Fiberoptic Light
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.