| Primary Device ID | 00860011812180 |
| NIH Device Record Key | 7c80929a-4049-4ff3-9d33-6b4413b7bd5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InnoVoyce VYLO Cart |
| Version Model Number | A |
| Catalog Number | LC-00455 |
| Company DUNS | 118104468 |
| Company Name | Innovoyce 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com | |
| Phone | 617 865 9401 |
| info@innovoyce.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011812180 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-17 |
| Device Publish Date | 2025-02-07 |
| 00860004755982 - InnoVoyce VYLO Laser | 2025-02-17 InnoVoyce VYLO 30W 455nm Laser |
| 00860004755999 - InnoVoyce VYLO Eye Safety Filter Leica | 2025-02-17 InnoVoyce VYLO Eye Safety Filter Leica |
| 00860011812104 - InnoVoyce VYLO Eye Safety Filter Zeiss | 2025-02-17 InnoVoyce VYLO Eye Safety Filter Zeiss |
| 00860011812111 - InnoVoyce VYLO Footswitch | 2025-02-17 InnoVoyce VYLO Footswitch |
| 00860011812180 - InnoVoyce VYLO Cart | 2025-02-17InnoVoyce VYLO Cart |
| 00860011812180 - InnoVoyce VYLO Cart | 2025-02-17 InnoVoyce VYLO Cart |
| 00860004755913 - InnoVoyce LLC | 2024-08-20 KTP Laser Fiber 600 |
| 00860004755906 - InnoVoyce LLC | 2024-08-05 KTP Laser Fiber 400 |
| 10860004755903 - InnoVoyce LLC | 2024-08-05 KTP Laser Fiber 600 |