Sterilizable Handles
Sterilizable Central Handle, 1 pc
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 | Baxter Medical Systems GmbH + Co. KG, Germany |
|---|---|
| FDA product code | FSQ |
| Device type | Light, Surgical, Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-07-11 |
| Record revised | 2024-04-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
| Packaging | Pack of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4023312 | 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 |
| Rutilight | Swan Medical SL | 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.