| Primary Device ID | 00810027860620 |
| NIH Device Record Key | 208c2a24-13b9-48b5-be36-f101fc4a621e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One Stage TL Implant |
| Version Model Number | I3053020 |
| Company DUNS | 026108395 |
| Company Name | I3 IMPLANT 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |