Zentrum LEG Section, Right, US
Catalogue number 8000-23-U, listed by Mizuho Orthopedic Systems, Inc., 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 | Mizuho Orthopedic Systems, Inc., United States |
|---|---|
| FDA product code | GDC |
| Device type | Table, Operating-Room, Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-11-27 |
| Record revised | 2024-02-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment atmospheric pressure 75 to 105 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature 23 to 113 °F |
| Distribution end date | 2024-01-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8000-23-U | Withdrawn |
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
2 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 |
|---|---|---|---|---|---|
| 2021-02-08 | Class II | Nonconforming Material/Component | There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure. | 26 units | |
| 2015-12-14 | Class II | Employee error | Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the | 33 | 2016-02-10 |
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.