| Primary Device ID | 07630813462219 |
| NIH Device Record Key | c23fa877-89b6-4424-a0c6-5d7d6af8aa9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TCR Mono |
| Version Model Number | 756203 |
| Catalog Number | 756203 |
| Company DUNS | 480467422 |
| Company Name | Candulor AG |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630813462219 [Primary] |
| HIBCC | E1997562031 [Previous] |
| ELM | Denture, plastic, teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
| E1997562051 | TCR Mono D2 98.5-20MM |
| E1997562041 | TCR Mono C2 98.5-20MM |
| E1997562031 | TCR Mono B3 98.5-20MM |
| E1997562021 | TCR Mono B1 98.5-20MM |
| E1997562011 | TCR Mono A3.5 98.5-20MM |
| E1997562001 | TCR Mono A3 98.5-20MM |
| E1997561991 | TCR Mono A2 98.5-20MM |
| E1997561981 | TCR Mono A1 98.5-20MM |
| E1997561971 | TCR Mono BL3 98.5-20MM |
| 07630813462219 | TCR Mono B3 98.5-20MM |
| 07630813462196 | TCR Mono A3.5 98.5-20MM |
| 07630813462189 | TCR Mono A3 98.5-20MM |
| 07630813462172 | TCR Mono A2 98.5-20MM |
| 07630813462158 | TCR Mono BL3 98.5-20MM |