| Primary Device ID | D757D46502S0 |
| NIH Device Record Key | acec9ed9-b7ba-4c89-a452-43fc63fb9a35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraCem Ca |
| Version Model Number | D-46502S |
| Catalog Number | D-46502S |
| Company DUNS | 053529939 |
| Company Name | BISCO INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 847-534-6000 |
| sales@bisco.com |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D757D46502S0 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-10 |
| Device Publish Date | 2018-03-02 |
| D757D46502S0 | THERACEM Ca 1G DUAL SYR SAMPLE |
| D757D46502PS0 | THERACEM Ca 1g DUAL SYR SMPL PKG |
| D757D465010 | THERACEM Ca 8g DUAL SYRINGE |
| 00810111541312 | THERACEM Ca 8g REFILL PACKAGE |
| 00810111541336 | THERACEM Ca 1g DUAL SYR SMPL PKG |
| 00810111541305 | THERACEM Ca 8g DUAL SYRINGE |