| Primary Device ID | 00190837175177 |
| NIH Device Record Key | 0e4c8a44-e606-489a-b84c-870542792c94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARx SAI |
| Version Model Number | 18-8570-09 |
| Company DUNS | 183641617 |
| Company Name | Life Spine, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00190837175177 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
[00190837175177]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-12 |
| Device Publish Date | 2024-12-04 |
| 00190837175382 | 18-9570-09 |
| 00190837175238 | 18-85100-09 |
| 00190837175191 | 18-8580-09 |
| 00190837175177 | 18-8570-09 |
| 00190837175214 | 18-8590-09 |