| Primary Device ID | M724TMSXL61 |
| NIH Device Record Key | 865bbd6d-18f7-412f-ad6e-deabee00693f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Terino Malar Shell® |
| Version Model Number | Size: X-Large (6mm) |
| Catalog Number | TMS-XL6 |
| Company DUNS | 784664955 |
| Company Name | IMPLANTECH ASSOCIATES, INC. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |