| Primary Device ID | 08800037559500 |
| NIH Device Record Key | d26a02ea-1f43-4d21-8c3c-e1ee657bbb60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Global Spinal Fixation System™ |
| Version Model Number | SG8135 |
| Company DUNS | 688811082 |
| Company Name | U&I CORPORATION |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 08800037559500 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
[08800037559500]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-20 |
| Device Publish Date | 2023-02-12 |