| Primary Device ID | 00385640023085 |
| NIH Device Record Key | 6dfdcd4e-3e0e-47ec-9481-334442f4a1fe |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | VC-49006 |
| 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 | true |
| Expiration Date | false |
| 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 | 00385640023085 [Primary] |
| ETD | Tube, Tympanostomy |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
[00385640023085]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-08 |
| 00385640090094 - INSTRUSAFE | 2026-02-18 |
| 00385640090070 - INSTRUSAFE | 2026-02-17 |
| 00385640090087 - INSTRUSAFE | 2026-02-17 |
| 00385640090025 - INSTRUSAFE | 2026-02-12 |
| 00385640090032 - INSTRUSAFE | 2026-02-12 |
| 20385640090005 - Walcott | 2026-02-11 |
| 20385640090012 - Walcott | 2026-02-11 |
| 40385640090016 - Walcott | 2026-02-11 |