| Primary Device ID | 08800015933292 |
| NIH Device Record Key | fab5f711-040d-4206-a2ad-2a03eafedee4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Global Spinal Fixation System™ |
| Version Model Number | SG1804CS |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800015933292 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
[08800015933292]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-17 |
| Device Publish Date | 2016-10-01 |