| Primary Device ID | 04250480100363 |
| NIH Device Record Key | 2e9d0a75-230e-4961-82a8-f8273872c672 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 05.0112c |
| Company DUNS | 316276682 |
| Company Name | SCHÖLLY FIBEROPTIC GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| 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 |
| Storage Environment Humidity | Between 5 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250480100363 [Primary] |
| NTN | Led Light Source |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250480100363]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04250480100363]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04250480100363]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-23 |
| Device Publish Date | 2025-01-15 |
| 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 |
| 04250480100356 - NA | 2025-01-23 Adapter light guide, Wolf Endoscope |
| 04250480100363 - NA | 2025-01-23Adapter light guide, ACMI endoscope |
| 04250480100363 - NA | 2025-01-23 Adapter light guide, ACMI endoscope |
| 04250480101759 - NA | 2025-01-23 Laparoscope 10 x 344mm, 0° RL-100 |