UnoDent
UnoDent Panoramic X-Ray Film Green Sensitive 12 x 30 cm
3manufacturers in China registered for this device type
4catalogue 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 | Flow X-Ray Corp., United States |
|---|---|
| FDA product code | IWZ |
| Device type | Film, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1840 |
| Premarket notification | Exempt |
| Record published | 2020-07-01 |
| Record revised | 2023-06-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 30 to 50 % RH; Handling environment temperature 10 to 21 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| XGU170 | 100 | In distribution | |
| XAU000 | 150 | In distribution | |
| XGU171 | 100 | In distribution | |
| XAU010 | 150 | 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.