Clarity
Catalogue number 3008, listed by Skytron, LLC, United States, under Table, Operating-Room, Electrical. 29 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (7), Guangdong (5), Hebei (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Hebei Jiede Medical Equipment Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 20 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| 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 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang | Liaoning | Manufacturer | 24 |
Showing 12 of 29. All 29 manufacturers in China registered for Table, Operating-Room, Electrical
Record
| Listed by | Skytron, LLC, United States |
|---|---|
| FDA product code | GDC |
| Device type | Table, Operating-Room, Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 30 to 60 % RH; Handling environment temperature 15 to 30 °C; Storage environment humidity 10 to 85 % RH; Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3008 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 115 |
| Nuvo | Medical Illumination International, Inc | 94 |
| Operon | Berchtold Gmbh & Co. KG | 85 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 58 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 53 |
| Medstone | Stille AB | 41 |
| imagiQ | Stille AB | 37 |
| Leg Traction Device | Mizuho Corporation | 35 |
| Radiographic Tops Fixed Type | Mizuho Corporation | 33 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 28 |
| Operating Table MOT-VS500 | Mizuho Corporation | 24 |
| Allen | Hill-ROM, Inc. | 22 |
Showing 12 of 273. All products under Table, Operating-Room, Electrical
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-08-01 | Class II | Under Investigation by firm | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communicat | 110 units | |
| 2023-08-01 | Class II | Under Investigation by firm | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communicat | 24 units | |
| 2016-04-06 | Class II | Reprocessing Controls | The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to | 458 | 2017-07-20 |
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.