| Primary Device ID | 00850015110030 |
| NIH Device Record Key | 37fed039-8282-4ca7-964d-4f906b061479 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TEMREX POWDER |
| Version Model Number | 330 25gm. White |
| Company DUNS | 012072823 |
| Company Name | TEMREX CORPORATION |
| 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 | false |
| 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 | 00850015110030 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-21 |
| Device Publish Date | 2020-02-13 |
| 00850015110184 | POWDER FOR MIXING WITH DENTAL CEMENT LIQUID |
| 00850015110177 | POWDER FOR MIXING WITH DENTAL CEMENT LIQUID |
| 00850015110160 | POWDER FOR MIXING WITH DENTAL CEMENT LIQUID |
| 00850015110153 | POWDER FOR MIXING WITH DENTAL CEMENT LIQUID |
| 00850015110146 | POWDER FOR MIXING WITH DENTAL CEMENT LIQUID |
| 00850015110139 | POWDER FOR MIXING WITH DENTAL CEMENT LIQUID |
| 00850015110122 | POWDER FOR MIXING WITH DENTAL CEMENT LIQUID |
| 00850015110030 | POWDER FOR MIXING WITH CEMENT LIQUID |