| Primary Device ID | H65810038361 |
| NIH Device Record Key | 70c3e259-ffe2-40c0-807e-be576a69e1b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Temporary Cement Remover |
| Version Model Number | 1005168 |
| Catalog Number | 1005168 |
| Company DUNS | 012430880 |
| Company Name | HENRY SCHEIN, 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 | 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 | 00304040028926 [Primary] |
| HIBCC | H65810038361 [Secondary] |
| FLG | Cleaner, ultrasonic, medical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-27 |
| Device Publish Date | 2024-02-19 |
| 00304040194775 - Henry Schein | 2026-02-04 Custom Plastics Pack |
| 00304040194812 - Henry Schein | 2026-02-04 Abdominoplasty Pack |
| 00304040194829 - Henry Schein | 2026-02-04 Basic Pack PSSC002-01 (TBD) |
| 00304040194836 - Henry Schein | 2026-02-04 Breast Pack PSSC003-01 (TBD) |
| 00304040194843 - Henry Schein | 2026-02-04 Head and Neck Pack PSSC004-01 (TBD) |
| 00304040194782 - Henry Schein | 2026-01-28 Essentials Mixing Tips Large |
| 00304040194799 - Henry Schein | 2026-01-28 Essentials Mixing Tips Small |
| 00304040194805 - Henry Schein | 2026-01-28 Essentials Intraoral Tips |