| Primary Device ID | 20789594000019 |
| NIH Device Record Key | 18a66661-f3b8-424c-bed0-e20585024f29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Septaline |
| Version Model Number | 292144 |
| Catalog Number | 292144 |
| Company DUNS | 929236305 |
| Company Name | YOUNG MICROBRUSH, LLC |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00789594000015 [Primary] |
| GS1 | 10789594000012 [Package] Package: CARTON [400 Units] In Commercial Distribution |
| GS1 | 20789594000019 [Package] Contains: 00789594000015 Package: CASE [50 Units] In Commercial Distribution |
| KXR | APPLICATOR, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-22 |
| Device Publish Date | 2022-08-13 |
| 20789594000019 | Septaline Disposable Micro-Applicators M8 Regular 2.0mm, Assorted Colors, Blue & Green |
| 10789594000005 | Septaline Disposable Micro-Applicators M8 Fine 1.5mm, Assorted Colors, Pink & Yellow |