| Primary Device ID | 15060753520004 |
| NIH Device Record Key | a244816d-c4c7-41d8-93e5-6a9d14a9d2ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tympa Otoscope System |
| Version Model Number | iPhone XR |
| Company DUNS | 223449035 |
| Company Name | TYMPA HEALTH TECHNOLOGIES LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |