| Primary Device ID | 04548190121748 |
| NIH Device Record Key | 54b1fea7-6abf-4732-ba72-55a224757789 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Estelite Flow Quick High Flow |
| Version Model Number | 12174 |
| Company DUNS | 693552176 |
| Company Name | TOKUYAMA DENTAL CORPORATION |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190121748 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 04548190123919 | Syringe A2 Mini |
| 04548190121748 | Syringe OPA2 |
| 04548190121731 | Syringe A3 |
| 04548190121724 | Syringe A2 |
| 04548190121717 | Syringe A1 |
| 04548190120840 | PLT OPA2 |
| 04548190120833 | PLT A3 |
| 04548190120826 | PLT A2 |
| 04548190120819 | PLT A1 |