| Primary Device ID | 00810028393486 |
| NIH Device Record Key | b6d0a3a5-01b1-40fc-85c3-0842a1cbceae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 7mm STAR E+ Sliding Core STAR Total Ankle |
| Version Model Number | 602-03-007 |
| Company DUNS | 828829072 |
| Company Name | Trilliant Surgical, 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810028393486 [Primary] |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-14 |
| Device Publish Date | 2024-08-06 |
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| 00810028393479 - 6mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |
| 00810028393486 - 7mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |
| 00810028393486 - 7mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |
| 00810028393493 - 8mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |
| 00810028393509 - 9mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |
| 00810028393516 - 10mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |
| 00810028393523 - 11mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |
| 00810028393530 - 12mm STAR E+ Sliding Core STAR Total Ankle | 2024-08-14 |