| Primary Device ID | 00385640001540 |
| NIH Device Record Key | 58f4de4a-5412-42ef-9cab-a070026e6667 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | VT-0802-01 |
| 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 | 00385640001540 [Primary] |
| GS1 | 10385640001547 [Package] Package: Box [6 Units] In Commercial Distribution |
| GS1 | 20385640001544 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-12 |
| 00385640083881 - INSTRUSAFE | 2024-11-19 |
| 00385640083898 - INSTRUSAFE | 2024-11-19 |
| 00385640083874 - INSTRUSAFE | 2024-11-18 |
| 00385640083836 - INSTRUSAFE | 2024-11-15 |
| 00385640083843 - INSTRUSAFE | 2024-11-15 |
| 00385640083850 - INSTRUSAFE | 2024-11-15 |
| 00385640083867 - INSTRUSAFE | 2024-11-15 |
| 00385640083805 - INSTRUSAFE | 2024-11-14 |