| Primary Device ID | 00385640001304 |
| NIH Device Record Key | cf610b06-db75-45ca-bb90-d953204aedfb |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | VT-0503-01 |
| 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 | 00385640001304 [Primary] |
| GS1 | 10385640001301 [Package] Package: Box [6 Units] In Commercial Distribution |
| GS1 | 20385640001308 [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 |
| 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 |