TL 5000/3000 – Surgical Light
TruLight 5000 / 3000 Ceiling Duo
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| HI-Life Technology (Hebei) Co., Ltd. | Bazhou | Hebei | Manufacturer | 11 |
| Shenzhen Youmay Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Record
| Listed by | Baxter Medical Systems GmbH + Co. KG, Germany |
|---|---|
| FDA product code | FTD |
| Device type | Lamp, Surgical |
| 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 |
|---|---|---|
| 4038210 | In distribution | |
| 4038140 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet PowerLED II | Maquet Gmbh | 1,930 |
| S300 Series | Dentis Co., Ltd. | 41 |
| Standop Volista® | Maquet Gmbh | 32 |
| L400 Series | Dentis Co., Ltd. | 24 |
| M400 Series (Ceiling, Mobile) | Dentis Co., Ltd. | 24 |
| Lamp, Surgical | Maquet Gmbh | 18 |
| Maquet Ezea | Maquet Gmbh | 18 |
| Maisilide | Shandong Deman Medical Equipment Group Co., Ltd. | 15 |
| S250 Series(Ceiling, Mobile) | Dentis Co., Ltd. | 11 |
| Lucea LED® | Maquet Gmbh | 7 |
| StarTrol | Huot Instruments, LLC | 7 |
| Rolite Volista Standop | Maquet Gmbh | 5 |
Showing 12 of 52. All products under Lamp, Surgical
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.