| Primary Device ID | D831PS202US0 |
| NIH Device Record Key | 7485c8a4-5c4a-44ac-99ea-a55b3eb1bf99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | primostick |
| Version Model Number | PS202US |
| Company DUNS | 153454736 |
| Company Name | PRIMOTEC LLC |
| 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 | 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 |
|---|---|
| HIBCC | D831PS202US0 [Primary] |
| MQC | Mouthguard, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-17 |
| Device Publish Date | 2021-11-09 |
| D831PS100US1 - Primosplint | 2021-11-17 |
| D831PS202US0 - primostick | 2021-11-17 |
| D831PS202US0 - primostick | 2021-11-17 |
| D831PS204US0 - primoglaze | 2021-11-17 |
| D831PSKIT1 - primosplint system | 2021-11-17 |
| D831TI10 - PREMIOtitan | 2020-09-07 |
| D831TI12 - PREMIOtitan | 2020-09-07 |
| D831TI135 - PREMIOtitan | 2020-09-07 |
| D831TI15 - PREMIOtitan | 2020-09-07 |