| Primary Device ID | 00850007069278 |
| NIH Device Record Key | a9a553fa-7ca0-4e2f-a7ec-2179fab0dfe8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MaxView™ System - Lateral Set |
| Version Model Number | VLS-M20 |
| Company DUNS | 096680671 |
| Company Name | VISEON, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com | |
| Phone | 949-662-3959 |
| customerservice@viseon-spine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007069278 [Primary] |
| FSO | Microscope, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-23 |
| Device Publish Date | 2021-11-15 |
| 00850007069308 | Spinal visualization system, long |
| 00850007069292 | Spinal visualization system, medium |
| 00850007069285 | Spinal visualization system, short |
| 00850007069278 | Spinal visualization system, long |
| 00850007069261 | Spinal visualization system, short |