| Primary Device ID | M724TMSXL71 |
| NIH Device Record Key | 9331b244-09c1-4205-95f6-b0157fe2e3ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Terino Malar Shell® |
| Version Model Number | Size: X-Large (7mm) |
| Catalog Number | TMS-XL7 |
| 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 |