| Primary Device ID | 00810131880217 |
| NIH Device Record Key | 967ba5f6-f6cc-4fbf-a8ce-1edc71e3fba0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiLink-P Disposable Inserter Main Body |
| Version Model Number | SR20-3400 |
| Company DUNS | 004095409 |
| Company Name | SURGENTEC, LLC |
| 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 | true |
| 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 | 00810131880217 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-08 |
| Device Publish Date | 2024-10-31 |
| 00810131880026 - SI-Lateral Ratcheting T-Handle | 2024-11-11 |
| 00810131880071 - TiLink-L Transfer Pin | 2024-11-11 |
| 00810131880248 - TiLink-L Implant Caddy | 2024-11-11 |
| 00810131880255 - TiLink-L Sterilization Tray | 2024-11-11 |
| 00810131880316 - TiLink-L Reamer | 2024-11-11 |
| 00810131880378 - TiLink-L Bone Graft Funnel | 2024-11-11 |
| 00810131880385 - TiLink-L Bone Graft Pusher Assembly | 2024-11-11 |
| 00810131880415 - Guidewire - 15.5" | 2024-11-11 |