| Primary Device ID | 04548190101313 |
| NIH Device Record Key | 98f15e15-b7a7-424e-bd25-309dd980af7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OMNICHROMA BLOCKER |
| Version Model Number | 10131 |
| Company DUNS | 693552176 |
| Company Name | TOKUYAMA DENTAL CORPORATION |
| Device Count | 10 |
| 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 | 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 | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com | |
| Phone | 1-877-378-3548 |
| info@tokuyama-us.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190101313 [Primary] |
| GS1 | 94548190101316 [Unit of Use] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-03 |
| Device Publish Date | 2018-04-02 |
| 04548190101337 | Syringe Sample |
| 04548190101313 | PLT Sample |
| 04548190101276 | PLT |
| 04548190101177 | SYRINGE |