TL 5000/3000 – Surgical Light
TruLight 5000 / 3000 Ceiling Trio
14manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang | Liaoning | Manufacturer | 24 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
| Hebei Webian Medical Instrument Trading Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Zhejiang Honsun Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Lamp, Operating-Room
Record
| Listed by | Baxter Medical Systems GmbH + Co. KG, Germany |
|---|---|
| FDA product code | FQP |
| Device type | Lamp, Operating-Room |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-05 |
| Record revised | 2023-02-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4038310 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 20 |
| SynFrame | Synthes Gmbh | 13 |
| SLS 9000 | Avante | 8 |
| Helux Pro Surgical Light | Baxter Medical Systems GmbH + Co. KG | 6 |
| SLS 2500 | Avante | 5 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 4 |
| SLS 6000 | Avante | 3 |
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 3 |
| TruLight | Baxter Medical Systems GmbH + Co. KG | 3 |
| Lamp, Operating-Room | Synthes Gmbh | 2 |
| Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | 2 |
| iLED7 Surgical Light | Baxter Medical Systems GmbH + Co. KG | 2 |
Showing 12 of 17. All products under Lamp, Operating-Room
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2024-06-04 | Class II | Under Investigation by firm | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes a | 5 units |
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.