| Primary Device ID | 00190837175443 |
| NIH Device Record Key | 22baf23f-e370-477d-ace4-356e4548861d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARx SAI |
| Version Model Number | 18-95100-09 |
| 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 | 00190837175443 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
[00190837175443]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-13 |
| Device Publish Date | 2025-01-03 |