| Primary Device ID | 00348783005684 |
| NIH Device Record Key | 19043960-10bb-4b5f-aaa0-dd028db4b1b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AeroPro Barriers |
| Version Model Number | 5500530 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00348783005684 [Primary] |
| GS1 | 10348783005681 [Package] Package: case [36 Units] In Commercial Distribution |
| PEM | Dental Barriers And Sleeves |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
| 00348783000672 - Brite Shield | 2024-06-28 BRITE SHIELD SAMPLE (1pk) |
| 00348783000696 - CompCORE | 2024-06-28 CompCore Natural Shade - 50 gr |
| 00348783000702 - CompCORE | 2024-06-28 CompCore Natural Shade - 28 gr |
| 00348783003796 - Brite Shield | 2024-06-28 BRITE SHIELD (CASE OF 6) |
| 00348783003802 - Brite Shield | 2024-06-28 Brite Shield Sample INTL w/Illustration Card |
| 00348783003819 - Brite Shield | 2024-06-28 CLEANER SAMPLE PACK (BS/VA) |
| 00348783003826 - Pro Clean | 2024-06-28 PRO CLEAN STAIN CLEANER (SINGLE BOX of 25) |
| 00348783003833 - Pro Clean | 2024-06-28 PRO CLEAN STAIN CLEANER (CASE OF 10) |