| Primary Device ID | 04250480104200 |
| NIH Device Record Key | 861795dc-0e20-41d6-88f6-4a32ee3d0381 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 95-3909 |
| Company DUNS | 316276682 |
| Company Name | SCHÖLLY FIBEROPTIC GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250480104200 [Primary] |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
[04250480104200]
Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-19 |
| Device Publish Date | 2025-06-11 |
| 04250480104200 - NA | 2025-06-19NIR FI+ Camera Head Full 4K UHD |
| 04250480104200 - NA | 2025-06-19 NIR FI+ Camera Head Full 4K UHD |
| 04250480104262 - N/A | 2025-06-19 NIR FI+ Light Source |
| 04250480103906 - NA | 2025-04-17 Cystoscope 2.7 mm x 110 mm, 0° |
| 04250480100271 - NA | 2025-01-23 Adapter light guide, Storz light source |
| 04250480100288 - NA | 2025-01-23 Adapter light guide, Olympus light source |
| 04250480100295 - NA | 2025-01-23 Adapter light guide, Wolf light source |
| 04250480100325 - NA | 2025-01-23 Adapter light guides, ACMI light source |
| 04250480100349 - NA | 2025-01-23 Adapter light guide, Storz endoscope |