| Primary Device ID | 02816901022274 |
| NIH Device Record Key | 153a699a-3560-4e3a-aed5-a0ff57df15e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | LFS-600-SF |
| Catalog Number | 098751 |
| Company DUNS | 039281260 |
| Company Name | LEONI FIBER OPTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816901022276 [Primary] |
| GS1 | 01816901022275 [Package] Contains: 00816901022276 Package: [5 Units] In Commercial Distribution |
| GS1 | 02816901022274 [Package] Contains: 01816901022275 Package: [25 Units] In Commercial Distribution |
| GEX | Powered laser surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-09 |
| Device Publish Date | 2021-04-01 |
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| 02816901023769 - NeuLight® | 2022-11-14 |