| Primary Device ID | 00840277406989 |
| NIH Device Record Key | 0e9be4db-2192-478c-847b-283de743752b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MaxLite Elite |
| Version Model Number | MG8-SK-MX |
| 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 | 00840277406989 [Primary] |
| 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 | 2024-12-25 |
| Device Publish Date | 2024-12-17 |
| 00840277407030 | Charger 4-Bay Set (INT'L) |
| 00840277407023 | Charger 4-Bay Console |
| 00840277407016 | MaxLite Elite Demo Kit |
| 00840277407009 | MaxLite Elite Headband |
| 00840277406996 | MaxLite Elite G8 Hospital Kit |
| 00840277406989 | MaxLite Elite G8 Standard Kit |
| 00840277406972 | MaxLite Elite G6 Hospital Kit |
| 00840277406965 | MaxLite Elite G6 Standard Kit |
| 00840277406958 | MaxLite Elite G3 Hospital Kit |
| 00840277406941 | MaxLite Elite G3 Standard Kit |