Operon
Berchtold Surgical Table, D 820
29manufacturers in China registered for this device type
85catalogue numbers in this listing
3recalls on this 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 | Berchtold Gmbh & Co. KG, Germany |
|---|---|
| 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 | 2019-08-27 |
| Record revised | 2025-06-16 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 85 % RH; Storage environment temperature -10 to 50 °C; Storage environment humidity 10 to 85 % RH; Handling environment temperature -10 to 50 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Distribution end date | 2022-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OT 7701076 | In distribution | |
| OT 7701075 | In distribution | |
| OT 7701066 | In distribution | |
| OT 8302175 | In distribution | |
| OT 8601165 | In distribution | |
| OT 8602075 | In distribution | |
| OT 8301065 | In distribution | |
| OT 8601065 | In distribution | |
| OT 8602175 | In distribution | |
| OT 8301075 | In distribution | |
| OT 8601075 | In distribution | |
| OT 8301175 | In distribution | |
| OT 8204575 | In distribution | |
| OT 8204675 | In distribution | |
| OT 8301165 | In distribution | |
| OT 8601175 | In distribution | |
| OT 8302075 | In distribution | |
| OT 8302165 | In distribution | |
| OT 8302065 | In distribution | |
| OT 8602065 | In distribution | |
| OT 8602165 | In distribution | |
| OT 7701065 | In distribution | |
| OT 7606575 | In distribution | |
| OT 8202105 | Withdrawn | |
| OT 7608514 | Withdrawn | |
| OT 1702004 | Withdrawn | |
| OT 8204504 | Withdrawn | |
| OT 9998502 | Withdrawn | |
| OT 8204605 | Withdrawn | |
| OT 1704614 | Withdrawn | |
| OT 8202075 | Withdrawn | |
| OT 8204614 | Withdrawn | |
| OT 9998500 | Withdrawn | |
| OT 1704505 | Withdrawn | |
| OT 1701175 | Withdrawn | |
| OT 1801275 | Withdrawn | |
| OT 8204506 | Withdrawn | |
| OT 1702114 | Withdrawn | |
| OT 7608505 | Withdrawn | |
| OT 7606675 | Withdrawn | |
| OT 8202106 | Withdrawn | |
| OT 1702104 | Withdrawn | |
| OT 8204606 | Withdrawn | |
| OT 8204505 | Withdrawn | |
| OT 8202005 | Withdrawn | |
| OT 1704604 | Withdrawn | |
| OT 9998501 | Withdrawn | |
| OT 1702105 | Withdrawn | |
| OT 1801004 | Withdrawn | |
| OT 8202014 | Withdrawn | |
| OT 9997600 | Withdrawn | |
| OT 8202004 | Withdrawn | |
| OT 8204604 | Withdrawn | |
| OT 8202104 | Withdrawn | |
| OT 9998205 | Withdrawn | |
| OT 1702106 | Withdrawn | |
| OT 1812075 | Withdrawn | |
| OT 7608614 | Withdrawn | |
| OT 1802004 | Withdrawn | |
| OT 7608604 | Withdrawn | |
| OT 1811075 | Withdrawn | |
| OT 7608504 | Withdrawn | |
| OT 1702014 | Withdrawn | |
| OT 7608506 | Withdrawn | |
| OT 1702075 | Withdrawn | |
| OT 1702175 | Withdrawn | |
| OT 9998200 | Withdrawn | |
| OT 8202006 | Withdrawn | |
| OT 1704506 | Withdrawn | |
| OT 9998201 | Withdrawn | |
| OT 1701075 | Withdrawn | |
| OT 9998202 | Withdrawn | |
| OT 1802075 | Withdrawn | |
| OT 1702006 | Withdrawn | |
| OT 8202175 | Withdrawn | |
| OT 8202114 | Withdrawn | |
| OT 9997601 | Withdrawn | |
| OT 1704504 | Withdrawn | |
| OT 7608606 | Withdrawn | |
| OT 1812104 | Withdrawn | |
| OT 1704514 | Withdrawn | |
| OT 1801075 | Withdrawn | |
| OT 7606604 | Withdrawn | |
| OT 7608605 | Withdrawn | |
| OT 8204514 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 115 |
| Nuvo | Medical Illumination International, Inc | 94 |
| 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 |
| Table, Operating-Room, Electrical | Mizuho Corporation | 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 |
|---|---|---|---|---|---|
| 2013-03-12 | Class II | Device Design | The firm received complaints for unintended movements. | 3763 | 2017-05-08 |
| 2012-04-16 | Class II | Nonconforming Material/Component | Table was not lowering. | 263 | 2013-09-10 |
| 2009-02-02 | Not classified | Device Design | Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver’s finger which became stuck in metal latch under the gas cylinder of the bed piece. | 453 units | 2009-06-04 |
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.