DEXcam4™ Intra-Oral Camera Sheaths
2 catalogue numbers from 1.011.4989, listed by Dexis, LLC, United States, under Camera, Surgical And Accessories. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Guangdong (5), Shanghai (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 |
|---|---|---|---|---|
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shanghai Suoguang Visual Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Showing 12 of 22. All 22 manufacturers in China registered for Camera, Surgical And Accessories
Record
| Listed by | Dexis, LLC, United States |
|---|---|
| FDA product code | KQM |
| Device type | Camera, Surgical And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Handling environment temperature 10 to 40 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1.011.4989 | 100 | In distribution | |
| 1.011.4994 | 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Radiance | NDS Surgical Imaging, LLC. | 129 |
| Accu-Beam | Transamerican Technologies International | 114 |
| Barco | Barco, Inc | 89 |
| Conmed | ConMed Corporation | 59 |
| EndoVue | NDS Surgical Imaging, LLC. | 50 |
| Sony | Sony Corporation | 42 |
| CuratOR | Eizo Corporation | 38 |
| FSN | Foreseeson Custom Displays, Inc. | 25 |
| ILO | ILO Electronic Gmbh | 25 |
| Camera, Surgical And Accessories | Pentax of America, Inc. | 24 |
| Beacon | Shenzhen Beacon Display Technology Co., Ltd. | 24 |
| Tidishield | Tidi Products, LLC | 22 |
Showing 12 of 190. All products under Camera, Surgical And Accessories
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.