| Primary Device ID | 07290115935547 |
| NIH Device Record Key | 99f4bc45-f891-4e03-bab6-65ab72a9f6b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaLink Rod Inserter |
| Version Model Number | 83208 |
| Company DUNS | 649220779 |
| Company Name | PREMIA SPINE LTD |
| 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 | false |
| 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 | 07290115935547 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
[07290115935547]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-09 |
| Device Publish Date | 2024-10-01 |
| 07290115935547 | 83208 |
| 07290115932584 | 82601 |