| Primary Device ID | 00810111541312 |
| NIH Device Record Key | b0d5e11f-965f-497b-8bd4-23f924650281 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraCem Ca |
| Version Model Number | D-46501P |
| Catalog Number | D-46501P |
| Company DUNS | 053529939 |
| Company Name | BISCO INC. |
| 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 | false |
| 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 | 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 |
|---|---|
| GS1 | 00810111541312 [Primary] |
| HIBCC | D757D46501P1 [Previous] |
| EID | Syringe, Restorative And Impression Material |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2022-09-30 |
| 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 |