| Primary Device ID | 00840019970877 |
| NIH Device Record Key | 5f8096ac-82e0-4746-a388-e649f5bcba59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MD-Vue™ Lateral Access System |
| Version Model Number | 54-BK-4000 |
| Catalog Number | 54-BK-4000 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 00840019970877 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019970877]
Moist Heat or Steam Sterilization
[00840019970877]
Moist Heat or Steam Sterilization
[00840019970877]
Moist Heat or Steam Sterilization
[00840019970877]
Moist Heat or Steam Sterilization
[00840019970877]
Moist Heat or Steam Sterilization
[00840019970877]
Moist Heat or Steam Sterilization
[00840019970877]
Moist Heat or Steam Sterilization
[00840019970877]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-15 |
| Device Publish Date | 2025-07-07 |
| 00840019970877 | Table Arm Kit |
| 00840019970860 | Table Arm Case |
| 00840019970853 | Table Clamp |
| 00840019970846 | Table Arm |
| 00840019936248 | Suction Instruments - 12 Fr Long |