Rutilight
Catalogue number RL-01, listed by Swan Medical SL, Spain, under Light, Surgical, Instrument. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Qufu Lekang Medical Technology Group Co., Ltd. | Jining | Shandong | Manufacturer | 7 |
| Shandong Chenhong Medical Technology Co., Ltd. | Jining | Shandong | Manufacturer | 7 |
| Shenzhen Shanglaite Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Remanufacturer | 4 |
| Zhejiang Fude Medphotonic Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 4 |
| Shenzhen Yinghuada Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Swan Medical SL, Spain |
|---|---|
| FDA product code | FSQ |
| Device type | Light, Surgical, Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RL-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spotlight | Depuy Spine, Inc. | 9 |
| TruLight | Baxter Medical Systems GmbH + Co. KG | 9 |
| iLED | Baxter Medical Systems GmbH + Co. KG | 3 |
| iLED7 Surgical Light | Baxter Medical Systems GmbH + Co. KG | 2 |
| Sterilizable Handles | Baxter Medical Systems GmbH + Co. KG | 1 |
| TL 5000/3000 → Surgical Light | Baxter Medical Systems GmbH + Co. KG | 1 |
| Neo Surgical Lights | NEO Medical Inc. | 1 |
| Rutiside | Swan Medical SL | 1 |
| Rutilight power supply | Swan Medical SL | 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.