| Primary Device ID | 00856037005156 |
| NIH Device Record Key | 2468cee0-4790-4e77-bb7a-61482592a543 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiLink-P |
| Version Model Number | 20-26100815 |
| Catalog Number | 20-26100815 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856037005156 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-11-12 |
| 00856037005156 | TiLink-P 26mm x 10mm x 15mm x 8 deg |
| 00856037005149 | TiLink-P 26mm x 10mm x 13mm x 8 deg |
| 00856037005132 | TiLink-P 26mm x 10mm x 12mm x 8 deg |
| 00856037005101 | TiLink-P 26mm x 10mm x 9mm x 8 deg |
| 00856037005095 | TiLink-P 26mm x 10mm x 8mm x 8 deg |
| 00856037005088 | TiLink-P 26mm x 10mm x 7mm x 8 deg |
| 00856037005828 | TiLink-P - 26mm x 10mm x 9mm x 0° |
| 00856037005811 | TiLink-P - 26mm x 10mm x 8mm x 0° |
| 00856037005804 | TiLink-P - 26mm x 10mm x 12mm x 0° |
| 00856037005798 | TiLink-P - 26mm x 10mm x 11mm x 0° |
| 00856037005781 | TiLink-P - 26mm x 10mm x 10mm x 0° |