| Primary Device ID | 04250480101711 |
| NIH Device Record Key | 139471c6-97fb-4669-915a-193585058051 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SC-7000X |
| 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 |
| 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 | 04250480101711 [Primary] |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
[04250480101711]
Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-11 |
| Device Publish Date | 2024-12-03 |
| 04250480101704 - NA | 2024-12-11 Camera Control Unit VP-7000X |
| 04250480101711 - NA | 2024-12-11Camera Head SC-7000X |
| 04250480101711 - NA | 2024-12-11 Camera Head SC-7000X |
| 04250480101728 - NA | 2024-12-11 Light Guide 3.5 x 3000 mm LG-7000X |
| 04250480101735 - NA | 2024-12-11 Light Guide Adapter AL-7000X |
| 04250480112809 - NA | 2024-11-28 Light Guide 3.5 x 3000 mm, HT version |
| 04250480112816 - NA | 2024-11-28 Light Guide 4.8 x 3000 mm |
| 04250480112823 - NA | 2024-11-28 Light Guide 3.5 x 2300 mm, HT version |
| 04250480112830 - NA | 2024-11-28 Light Guide 4.8 x 2300 mm |