Henry Schein
X-Ray Film HSI Green Sensitive
3manufacturers in China registered for this device type
24catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | IWZ |
| Device type | Film, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1840 |
| Premarket notification | Exempt |
| Record published | 2019-04-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: CSH uses Humidity Limitation, Protect from heat and radioactive sources, as well as Temperature Limit. |
| Packaging | Pack of 5, 1125313 of 10, case of 50, 1125309 of 80, 1125317 of 10, case of 80 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1125313 | 50 | In distribution | |
| 9004286 | 100 | In distribution | |
| 1125333 | 150 | In distribution | |
| 1125309 | 100 | In distribution | |
| 9004285 | 100 | In distribution | |
| 9004283 | 100 | In distribution | |
| 1125317 | 50 | In distribution | |
| 1125310 | 100 | In distribution | |
| 1125316 | 50 | In distribution | |
| 9004288 | 100 | In distribution | |
| 9004287 | 100 | In distribution | |
| 9004289 | 100 | In distribution | |
| 1125314 | 50 | In distribution | |
| 1125334 | 150 | In distribution | |
| 9004284 | 100 | In distribution | |
| 1125307 | 150 | In distribution | |
| 1001243 | 150 | In distribution | |
| 1125333 | 150 | In distribution | |
| 1125306 | 150 | In distribution | |
| 1125310 | 100 | In distribution | |
| 1125332 | 100 | In distribution | |
| 1125328 | 50 | In distribution | |
| 1005871 | 150 | In distribution | |
| 1006107 | 100 | 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 |
| 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 |
| Medical X-ray Blue / MXB Film | 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.