| Primary Device ID | 04547410414530 |
| NIH Device Record Key | d497f3bb-09d2-4892-9ef2-1c6f227f69bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FDR SE Console |
| Version Model Number | DR-ID330CL |
| Company DUNS | 713565195 |
| Company Name | FUJIFILM CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx | |
| Phone | +018002728465 |
| xxx@xxx.xxx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04547410414530 [Primary] |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2019-12-13 |
| 04547410541199 - FUJIFILM | 2024-02-26 This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as pol |
| 04547410509984 - FUJIFILM | 2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s |
| 04547410509991 - FUJIFILM | 2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s |
| 04547410520903 - FUJIFILM | 2023-12-25 This product is intended to be used in combination with the FUJIFILM Leak Tester LT-100 to perform leak testing for a FUJIFILM e |
| 14547410520917 - FUJIFILM | 2023-12-25 This product is intended to check whether the FUJIFILM Leak Tester LT-100 can properly test the airtightness of a FUJIFILM endos |
| 04547410377248 - FUJIFILM | 2023-12-11 FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive tract, specifically for the observati |
| 04547410384536 - FUJIFILM | 2023-12-11 EI-580BT is a medical electronic endoscope intended to provide endoscopic images for observation, diagnosis, photographing and e |
| 14547410397649 - FUJIFILM | 2023-12-11 This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and end |