RadBoard®
2 catalogue numbers from 00884450203194, listed by Merit Medical Systems, Inc., United States, under Table And Attachments, Operating-Room. 34 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (12), Hebei (6), Guangdong (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Xuhe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 9 |
| Suzhou Baili Medical Supplies Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Suzhou Dukangning Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Hubei Yinkang Medical Equipment Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 8 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| Meixin Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 7 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Showing 12 of 34. All 34 manufacturers in China registered for Table And Attachments, Operating-Room
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | BWN |
| Device type | Table And Attachments, Operating-Room |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-02-16 |
| Record revised | 2025-05-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450203194 | In distribution | |
| 00884450278765 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flexarm Surgical Holders and Positioners | Flexbar Machine Corp. | 134 |
| StrongArm Surgical Holders and Positioners | Flexbar Machine Corp. | 91 |
| Table And Attachments, Operating-Room | Steris Corporation | 50 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 46 |
| Purist | Adsm | 32 |
| Flexarm Plus Surgical Holders and Positioners | Flexbar Machine Corp. | 32 |
| Head rest | Maquet Gmbh | 27 |
| Pair of leg plates | Maquet Gmbh | 25 |
| Arthrex® | Arthrex, Inc. | 21 |
| Extension plate | Maquet Gmbh | 15 |
| Back plate | Maquet Gmbh | 11 |
| Coulmed | Coulmed Products Group LLC | 10 |
Showing 12 of 379. All products under Table And Attachments, Operating-Room
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2013-12-18 | Class II | Labeling Change Control | Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to | 11 | 2014-02-13 |
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.