Vision XR
Vision XR Intraoral Film Single FB-58 F-Speed Box of 150
3manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rayco (Xiamen) Medical Products Company Limited | Xiamen | Fujian | Contract manufacturer | 1 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
Record
| Listed by | Benco Dental Supply Co. |
|---|---|
| FDA product code | IWZ |
| Device type | Film, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1840 |
| Premarket notification | Exempt |
| Record published | 2018-11-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4232-279 | In distribution | |
| 4232-224 | In distribution | |
| 4232-297 | In distribution | |
| 4232-340 | In distribution | |
| 4232-288 | In distribution | |
| 4232-331 | In distribution | |
| 4232-260 | In distribution | |
| 4232-313 | In distribution | |
| 4232-233 | In distribution | |
| 4232-242 | In distribution | |
| 4232-215 | In distribution | |
| 4232-251 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gafchromic™ | Ashland Specialty Ingredients, G.P. | 151 |
| Dryview DVB Laser Imaging Film | Carestream Health, Inc. | 42 |
| Imaging Plates | Palodex Group OY | 24 |
| Henry Schein | Henry Schein, Inc. | 24 |
| Fuji Medical X-RAY Film | Fujifilm Corporation | 21 |
| Ultra-speed | Carestream Health, Inc. | 17 |
| T-MAT G/RA Film | Carestream Health, Inc. | 16 |
| Dryview DVM Mammography Laser Imaging Film | Carestream Health, Inc. | 16 |
| E Blue X-ray Film WB | Carestream Health, Inc. | 15 |
| Medical X-ray Green / MXG Film | Carestream Health, Inc. | 15 |
| Rad Control | Typenex Medical, LLC | 15 |
| Insight | Carestream Health, Inc. | 15 |
Showing 12 of 259. All products under Film, Radiographic
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.