iLED
3 catalogue numbers from 4028310, listed by Baxter Medical Systems GmbH + Co. KG, Germany, under Light, Surgical, Instrument. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | 2016-09-17 |
| Record revised | 2024-08-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4028310 | Withdrawn | |
| 4028110 | Withdrawn | |
| 4068130 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spotlight | Depuy Spine, Inc. | 9 |
| TruLight | Baxter Medical Systems GmbH + Co. KG | 9 |
| iLED7 Surgical Light | Baxter Medical Systems GmbH + Co. KG | 2 |
| Rutilight | Swan Medical SL | 1 |
| 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.