| Primary Device ID | B366FE1023RX1 |
| NIH Device Record Key | 655b8072-adf2-4048-a289-445539d64c9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROCAM FLEX |
| Version Model Number | RX1 |
| Catalog Number | FE102/3 |
| Company DUNS | 043555079 |
| Company Name | Ecleris |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 786-483-7490 |
| ytzielo@ecleris.com | |
| Phone | 786-483-7490 |
| ytzielo@ecleris.com | |
| Phone | 786-483-7490 |
| ytzielo@ecleris.com |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B366FE1023RX1 [Primary] |
| FWD | Camera, Television, Microsurgical, Without Audio |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-01 |
| Device Publish Date | 2025-08-22 |
| B366AIO100BRX1 - PROCAM PACK | 2025-09-01 CAMERA WITH INTEGRATE SCREEN AND LIGHT SOURCE |
| B366AIO100SRX1 - PROCAM PACK S | 2025-09-01 CAMERA WITH INTEGRATE SCREEN AND LIGHT SOURCE |
| B366FE1023RX1 - PROCAM FLEX | 2025-09-01Procam FLEX |
| B366FE1023RX1 - PROCAM FLEX | 2025-09-01 Procam FLEX |
| B366U1VI2512R01 - PROCAM HD BASIC | 2025-09-01 PROCAM HD BASIC |
| B366U1VI360100BRX1 - PROCAM PACK | 2025-09-01 CAMERA WITH INTEGRATE SCREEN AND LIGHT SOURCE |
| B366U1VI360100SRX1 - PROCAM PACK S | 2025-09-01 CAMERA WITH INTEGRATE SCREEN AND LIGHT SOURCE |
| B366U1VI3604RX1 - PROCAM HD USB | 2025-09-01 Procam HD USB |
| B366U1HC120G21R06 - Procam HD CMOS II CONSOLE | 2025-08-07 Procam HD CMOS II CONSOLE |