| Primary Device ID | 00385640000451 |
| NIH Device Record Key | 0fff1f47-a8a9-475e-994d-817447006bc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Doyle P/F Nsal Pack |
| Version Model Number | RH-7412-10 |
| Catalog Number | RH-7412-10 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 00385640000451 [Primary] |
| GS1 | 10385640000458 [Package] Package: SHELF BOX [10 Units] In Commercial Distribution |
| LYA | Splint, Intranasal 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 | 2019-12-11 |
| Device Publish Date | 2016-08-17 |
| 00385640084604 - INSTRUSAFE | 2024-12-30 |
| 00385640084611 - INSTRUSAFE | 2024-12-30 |
| 00385640084628 - INSTRUSAFE | 2024-12-30 |
| 00385640084635 - INSTRUSAFE | 2024-12-30 |
| 00385640084642 - INSTRUSAFE | 2024-12-30 |
| 00385640084659 - INSTRUSAFE | 2024-12-30 |
| 00385640084666 - INSTRUSAFE | 2024-12-30 |
| 00385640084673 - INSTRUSAFE | 2024-12-30 |