| Primary Device ID | 04250480106174 |
| NIH Device Record Key | a8504327-6599-4800-bff2-20a9a40af8c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 41.0665a |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250480106174 [Primary] |
| FGA | Kit, Nephroscope |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250480106174]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2020-04-16 |
| 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 |