| Primary Device ID | 08056093610062 |
| NIH Device Record Key | 8b30d215-28fe-405f-b92a-13c6f5044236 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Doctor Smile |
| Version Model Number | Doctor Smile B-980 |
| Company DUNS | 428482616 |
| Company Name | LAMBDA SPA |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056093610062 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2016-12-15 |
| 08056093611120 | Doctor Smile handpieces (LAFIO0025.1) are designed for a fast and easy connection to the laser, |
| 08056093611083 | Fiber optic |
| 08056093611076 | Fiber optic |
| 08056093611069 | Fiber optic |
| 08056093611052 | Fiber optic |
| 08056093610093 | Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intende |
| 08056093610062 | Doctor Smile B-980 Laser (Doctor Smile D5 980 nm) is a standard diode medical laser with 980 nm |
| 08056093611137 | Doctor smile handpieces are designed for a fast and easy connection to the laser, for both denta |
| 08056093610284 | Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is inten |