| Primary Device ID | 00385640061926 |
| NIH Device Record Key | cce4bd2e-db6e-4af8-8b73-80f483724fc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ET-PSDT-1 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640061926 [Primary] |
| GS1 | 10385640061923 [Package] Package: Box [10 Units] In Commercial Distribution |
| ETD | Tube, Tympanostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-01-22 |
| Device Publish Date | 2020-11-10 |
| 00385640081030 - INSTRUSAFE | 2024-05-21 |
| 00385640081047 - INSTRUSAFE | 2024-05-21 |
| 00385640081023 - INSTRUSAFE | 2024-05-20 |
| 00385640081009 - INSTRUSAFE | 2024-05-15 |
| 00385640081016 - INSTRUSAFE | 2024-05-15 |
| 00385640080996 - INSTRUSAFE | 2024-05-14 |
| 00385640080972 - INSTRUSAFE | 2024-05-13 |
| 00385640080989 - INSTRUSAFE | 2024-05-13 |