| Primary Device ID | 00848956009544 |
| NIH Device Record Key | 00179738-2652-4e24-8990-3dbdba856036 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Angled Toothbrush |
| Version Model Number | 3184-100 |
| Catalog Number | 3184-100 |
| Company DUNS | 057680480 |
| Company Name | HEALTHMARK INDUSTRIES CO., INC. |
| Device Count | 2084895 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848956009544 [Unit of Use] |
| GS1 | 10848956009541 [Primary] |
| GS1 | 20848956009548 [Primary] |
| MNL | Accessories, Cleaning Brushes, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-08 |
| Device Publish Date | 2024-12-31 |
| 10848956020355 - N/A | 2025-06-26 SafeGuard Dry - Heavy - 24x24 in , 120 applications/case |
| 10848956020362 - N/A | 2025-06-26 SafeGuard Dry - Heavy - 36x36 in , 72 applications/case |
| 10848956020379 - N/A | 2025-06-26 SafeGuard Dry - Heavy - 40x40 in , 72 applications/case |
| 10848956020386 - N/A | 2025-06-26 SafeGuard Dry - Heavy - 45x45 in , 48 applications/case |
| 00848956020396 - N/A | 2025-06-26 SafeGuard Dry - Heavy - 48x48 in , 48 applications/case |
| 00848956020402 - N/A | 2025-06-26 SafeGuard Dry - Heavy - 54x54 in , 48 applications/case |
| 10848956007325 - Decontam Exam Gloves | 2025-01-08 S DECONTAM EXAM GLOVE - 14MIL |
| 10848956007332 - Decontam Exam Gloves | 2025-01-08 M DECONTAM EXAM GLOVE - 14MIL |