| Primary Device ID | 03760140704516 |
| NIH Device Record Key | 30603082-0653-444a-a7b0-2429b0b3bcf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioRoot RCS Liquid Refill Kit |
| Version Model Number | 01E0310 |
| Company DUNS | 275273795 |
| Company Name | SEPTODONT SAS SPECIALITES SEPTODONT |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-303-665-7535 |
| usregulatoryaffairs@septodont.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760140704516 [Primary] |
| KIF | Resin, Root Canal Filling |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-11 |
| Device Publish Date | 2019-07-03 |
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