Grid Entity
3 catalogue numbers from 7051, listed by Protec GmbH & Co. KG, Germany, under Holder, Radiographic Cassette, Wall-Mounted. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
Record
| Listed by | Protec GmbH & Co. KG, Germany |
|---|---|
| FDA product code | IXY |
| Device type | Holder, Radiographic Cassette, Wall-Mounted |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1880 |
| Premarket notification | Exempt |
| Record published | 2016-11-09 |
| Record revised | 2019-12-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 70 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 500 to 1060 millibar; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 700 to 1060 millibar |
| Distribution end date | 2019-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7051 | In distribution | |
| WR | In distribution | |
| DE2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Nederland B.V. | 38 |
| BR-120 | Shimadzu Corp. | 21 |
| BR-120T | Shimadzu Corp. | 19 |
| BR-120M | Shimadzu Corp. | 9 |
| Summit | Summit Industries, LLC | 8 |
| Holder, Radiographic Cassette, Wall-Mounted | Ge Hualun Medical Systems Co., Ltd. | 8 |
| Del Medical, Inc. | DEL Medical, Inc. | 7 |
| Sedecal | Sedecal., Sa. | 6 |
| Kenex | Kenex (Electro-Medical) Ltd. | 5 |
| QW-420-T | Carestream Health, Inc. | 5 |
| Discovery RF180 | General Medical Merate SPA | 4 |
| Drgem | Drgem Corporation | 3 |
Showing 12 of 54. All products under Holder, Radiographic Cassette, Wall-Mounted
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.