| Primary Device ID | 00385640000024 |
| NIH Device Record Key | 2588a4f8-859b-4330-8d58-ee9925324b5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nasal Septal Button 7CM |
| Version Model Number | SP-78107 |
| Catalog Number | SP-78107 |
| 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 | 00385640000024 [Primary] |
| LFB | Button, Nasal Septal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2016-08-09 |
| 00385640086035 - INSTRUSAFE | 2025-04-01 |
| 00385640086042 - INSTRUSAFE | 2025-04-01 |
| 00385640086011 - INSTRUSAFE | 2025-03-31 |
| 00385640086028 - INSTRUSAFE | 2025-03-31 |
| 00385640085984 - INSTRUSAFE | 2025-03-28 |
| 00385640085991 - INSTRUSAFE | 2025-03-28 |
| 00385640086004 - INSTRUSAFE | 2025-03-28 |
| 00385640085953 - INSTRUSAFE | 2025-03-27 |