| Primary Device ID | 04250480106099 |
| NIH Device Record Key | 46721632-1b88-4e8c-a709-a010fd4094f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 41.0671a |
| Company DUNS | 316276682 |
| Company Name | SCHÖLLY FIBEROPTIC GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250480106099 [Primary] |
| FGA | Kit, Nephroscope |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250480106099]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-27 |
| Device Publish Date | 2020-04-17 |
| 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 |
| 04250480109083 - NA | 2023-11-07 NIR FI CCU Full HD |
| 04250480109045 - N/A | 2023-11-01 NIR FI Light Source |