| Primary Device ID | 00385640001359 |
| NIH Device Record Key | ab054c46-d35d-4127-bfcf-8a22633f2a92 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | VT-0508-50 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00385640001359 [Primary] |
| GS1 | 10385640001349 [Package] Package: Box [6 Units] In Commercial Distribution |
| GS1 | 20385640001346 [Package] Package: Box [50 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 | 4 |
| Public Version Date | 2020-04-28 |
| Device Publish Date | 2016-09-12 |
| 00385640087674 - INSTRUSAFE | 2025-07-31 |
| 00385640087681 - INSTRUSAFE | 2025-07-31 |
| 00385640087698 - INSTRUSAFE | 2025-07-31 |
| 00385640087704 - INSTRUSAFE | 2025-07-31 |
| 00385640087711 - INSTRUSAFE | 2025-07-31 |
| 10385640086803 - SUMMIT MEDICAL | 2025-07-25 |
| 00385640087643 - INSTRUSAFE | 2025-07-24 |
| 00385640087650 - INSTRUSAFE | 2025-07-24 |