| Primary Device ID | 01816835024017 |
| NIH Device Record Key | fb6620b5-9988-4290-b8de-38d653490763 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IsoLED Plus+ LED HL |
| Version Model Number | IL-2410 |
| Company DUNS | 093357739 |
| Company Name | Medical Illumination International Inc. |
| 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 | 00816835024018 [Primary] |
| GS1 | 01816835024017 [Package] Contains: 00816835024018 Package: BOX [1 Units] In Commercial Distribution |
| FCT | Headlight, Fiberoptic Focusing |
| 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 | 2023-10-10 |
| Device Publish Date | 2023-10-02 |
| 01816835024048 | IsoLED Plus+ LED HL, w/ AC Power Pack, Carrying Case |
| 01816835024031 | IsoLED Plus+ LED HL, w/ AC Power Pack |
| 01816835024024 | IsoLED Plus+ LED HL, w/ Carrying Case |
| 01816835024017 | IsoLED Plus+ LED HL, Standard |