| Primary Device ID | 04250480108000 |
| NIH Device Record Key | cabce0f3-8d59-4e44-9b46-76e91d0722eb |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 95-3905 |
| Company DUNS | 316276682 |
| Company Name | SCHÖLLY FIBEROPTIC GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com | |
| Phone | 9999999999 |
| info@schoelly-usa.com |
| 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 |
| 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 | 04250480108000 [Primary] |
| FWF | Camera, Television, Endoscopic, Without Audio |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
[04250480108000]
Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-08 |
| Device Publish Date | 2020-04-30 |
| 04250480105603 - NA | 2024-09-20 Sealing caps, 10 pcs. pack, for instrument channel |
| 04250480105979 - NA | 2024-09-20 Three-slot membrane,10 pcs. pack, for instrument bridge |
| 04250480102329 - NA | 2023-11-07 Laparoscope 5 x 312 mm, 0° |
| 04250480102336 - NA | 2023-11-07 Laparoscope 5 x 312 mm, 30° |
| 04250480109038 - NA | 2023-11-07 NIR FI Light Guide, 4.8 x 3000 mm |
| 04250480109052 - NA | 2023-11-07 Laparoscope 10 x 344 mm, 0°, NIR |
| 04250480109069 - NA | 2023-11-07 Laparoscope 10 x 344 mm, 30°, NIR |
| 04250480109076 - NA | 2023-11-07 NIR FI Camera Head Full HD Zoom |