| Primary Device ID | 00850010501123 |
| NIH Device Record Key | e4df2f79-52f1-4cb6-85ca-e74d250fc3a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gemini EVO |
| Version Model Number | 9126 |
| Catalog Number | G2-5-005 |
| Company DUNS | 073483242 |
| Company Name | AZENA MEDICAL, LLC |
| 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 | true |
| Serial Number | false |
| 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 | 00850010501123 [Primary] |
| NVK | Laser, Dental, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-23 |
| Device Publish Date | 2022-05-13 |
| 00850010501086 | Gemini EVO Demo Laser Unit |
| 00850010501079 | Gemini EVO International Laser |
| 00850010501062 | Gemini EVO Domestic Laser |
| 00850010501130 | Refill/accessory for Gemini EVO laser handpiece shell |
| 00850010501123 | Refill/accessory for International Power supply for Gemini EVO |
| 00850010501116 | Refill/accessory for power supply for Gemini EVO |
| 00850010501109 | Refill accessory for Gemini EVO laser |
| 00850010501093 | Refill accessory for Gemini EVO kit |