| Primary Device ID | 10840277402704 |
| NIH Device Record Key | 080daab8-f376-4aa1-a211-18383596bc89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedLED Spectra |
| Version Model Number | M-90007 |
| Company DUNS | 964053560 |
| Company Name | RIVERPOINT MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840277402707 [Primary] |
| GS1 | 10840277402704 [Package] Contains: 00840277402707 Package: [2 Units] In Commercial Distribution |
| HPP | Headlamp, Operating, Battery-Operated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-13 |
| Device Publish Date | 2023-12-05 |
| 00810020080759 | Standard Kit |
| 00810020080704 | Standard Kit |
| 00810020080698 | Hospital Kit |
| 00810020080384 | Headlamp |
| 00810020080377 | Headlamp |
| 10840277402704 | Rechargeable Battery Set |
| 00840277404008 | MedLED Spectra® Headband Assembly |
| 00840277403445 | Carrying Bag Rugged |
| 00840277403216 | Charger 16-Bay Set |
| 00840277403209 | Charger 16-Bay Console |
| 00840277402752 | Headstrap Top Kit |
| 00840277402738 | Charger 4-Bay Console |
| 00840277402714 | Charger Wall Console |
| 00810020086683 | MG8 Bezel System Assembly |
| 00810020085815 | Rechargeable Battery Set (1 pc.) |