Paxis 100 Auto
Paxis 100 Auto Right Hand
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| 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 | Pausch, L.L.C. |
|---|---|
| FDA product code | IYB |
| Device type | Tube Mount, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1770 |
| Premarket notification | Exempt |
| Record published | 2023-05-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RH | In distribution | |
| RH | In distribution | |
| LH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 12 |
| CH-200 | Shimadzu Corp. | 7 |
| Summit | Summit Industries, LLC | 6 |
| CH-200M | Shimadzu Corp. | 6 |
| Sedecal | Sedecal., Sa. | 6 |
| Del Medical, Inc. | DEL Medical, Inc. | 6 |
| Tube Mount, X-Ray, Diagnostic | Ge Hualun Medical Systems Co., Ltd. | 4 |
| QS-500 | Carestream Health, Inc. | 4 |
| FH-21HR | Shimadzu Corp. | 4 |
| FH-20HR | Shimadzu Corp. | 3 |
| SS-2100 | Shinyoung FOR M Co., Ltd. | 2 |
| Universal | DEL Medical, Inc. | 2 |
Showing 12 of 38. All products under Tube Mount, X-Ray, Diagnostic
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.