| Primary Device ID | 00385640041072 |
| NIH Device Record Key | 4fca69d4-4fd2-4ae0-8d7f-7be31c0f377e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AbsorbENT Nasal Pack |
| Version Model Number | RH-7401-15 |
| Catalog Number | RH-7401-15 |
| 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 | 00385640041072 [Primary] |
| LYA | Splint, Intranasal Septal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2018-11-26 |
| 00385640041072 | RH-7401-15 |
| 00385640000444 | RH-7411-10 |
| 00385640000420 | RH-7409-10 |
| 00385640000413 | RH-7408-10 |
| 00385640000406 | RH-7406-10 |
| 00385640000390 | RH-7405-10 |
| 00385640000383 | RH-7404-10 |
| 00385640000376 | RH-7401-10 |