| Primary Device ID | 00385640000017 |
| NIH Device Record Key | c1ff5bef-8436-4a64-8773-2061f017fb24 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SP-78105 |
| Catalog Number | SP-78105 |
| 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 | 00385640000017 [Primary] |
| LFB | Button, Nasal Septal |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
[00385640000017]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2016-06-06 |
| 00385640090216 - INSTRUSAFE | 2026-02-27 |
| 00385640090209 - INSTRUSAFE | 2026-02-26 |
| 00385640090186 - INSTRUSAFE | 2026-02-25 |
| 00385640090193 - INSTRUSAFE | 2026-02-25 |
| 00385640090179 - INSTRUSAFE | 2026-02-24 |
| 00385640090155 - INSTRUSAFE | 2026-02-23 |
| 00385640090162 - INSTRUSAFE | 2026-02-23 |
| 00385640090094 - INSTRUSAFE | 2026-02-18 |