| Primary Device ID | 08809447657011 |
| NIH Device Record Key | 0e10afa5-604b-45f7-9a2d-abaf1e12532a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOSAIC 3D |
| Version Model Number | MOSAIC 3D |
| Company DUNS | 688282516 |
| Company Name | Lutronic Corporation |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com | |
| Phone | 408-912-1701 |
| jasonkim@lutronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809447657011 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-08 |
| Device Publish Date | 2025-11-28 |
| 08809447657448 | Sapphire Tip (S10 Tip) Package |
| 08809447657394 | Sapphire Tip (S20 Tip) Package |
| 08809447656960 | Pill Tip Package (Pill Tip 4ea) |
| 08809447657417 | Comb Tip Package (Comb Tip 4ea) |
| 08809447657387 | Roller Tip Package (Roller Tip 4ea + Roller Set 4set) |
| 08809447657370 | Sapphire Tip Package(S20 Tip 2ea + S10 Tip 2ea) (S20 Tip Unit of Use DI Number : 08809447657431, |
| 08809447657011 | MOSAIC 3D |