| Primary Device ID | 00861407000303 |
| NIH Device Record Key | 06b35bcb-6928-4dee-a10f-d1e85bc228df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gemini 810+980 Diode Laser |
| Version Model Number | EL-5-001 |
| 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 | true |
| 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 |
| Phone | 800-466-5273 |
| info@azenamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861407000303 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00861407000303]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-09-01 |
| 00861407000310 - Gemini | 2023-11-13 Gemini 5mm Tip - 25pk |
| 00861407000327 - Gemini | 2023-11-13 Gemini 7mm Tip - 25pk |
| 00861407000334 - Gemini | 2023-11-13 Gemini Safety Glasses |
| 00850010501093 - Gemini EVO | 2022-05-23 Refill accessory for Gemini EVO kit |
| 00850010501109 - Gemini EVO | 2022-05-23 Refill accessory for Gemini EVO laser |
| 00850010501116 - Gemini EVO | 2022-05-23 Refill/accessory for power supply for Gemini EVO |
| 00850010501123 - Gemini EVO | 2022-05-23 Refill/accessory for International Power supply for Gemini EVO |
| 00850010501130 - GEMINI EVO | 2022-05-23 Refill/accessory for Gemini EVO laser handpiece shell |