| Primary Device ID | 01816835024345 |
| NIH Device Record Key | 87f146bd-d131-4afa-9b13-3e4dfc7c3885 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SM1 |
| Version Model Number | SM1 |
| Company DUNS | 093357739 |
| Company Name | Medical Illumination International Inc. |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816835024346 [Primary] |
| GS1 | 01816835024345 [Package] Contains: 00816835024346 Package: BOX [1 Units] In Commercial Distribution |
| FST | Light, Surgical, Fiberoptic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-12 |
| Device Publish Date | 2024-09-04 |
| 01816835024345 - SM1 | 2024-09-12Solo, Monitor Arm |
| 01816835024345 - SM1 | 2024-09-12 Solo, Monitor Arm |
| 01816835024321 - MI-1000CAM | 2024-08-27 MI-1000, Single Ceiling Mount, with Camera option |
| 01816835024338 - MI-1000CAM | 2024-08-27 MI-1000, Dual Ceiling Mount, with Camera Option |
| 01816835023898 - Vu-E | 2024-04-10 Vu-E, TRIO, SURGICAL LGHT W/MONITOR ARM |
| 01816835024314 - SYSTEM TWO LED | 2024-01-26 SYSTEM TWO LED, TRIO, IL-CR & DUO SURGICAL LIGHT |
| 01816835024307 - SYSTEM TWO LED | 2024-01-10 SYSTEM TWO LED, DUO,IL-CR SURG LIGHT W/MON ARM |
| 00816835023950 - IsoLED Mini LED HL | 2023-10-10 IsoLED mini LEDHL, Standard, w/Mounting Clips |
| 01816835023966 - IsoLED Mini LED HL | 2023-10-10 IsoLED mini LEDHL, Attached to Safety Glasses |