| Primary Device ID | 00816594020276 |
| NIH Device Record Key | 42f5db93-eab3-469a-907d-a445b7797536 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCOLADE PV |
| Version Model Number | 90561 |
| Catalog Number | 90561 |
| Company DUNS | 601302743 |
| Company Name | DANVILLE MATERIALS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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(760)743-7744 |
| xxx@xxx.xxx | |
| Phone | +1(760)743-7744 |
| xxx@xxx.xxx | |
| Phone | +1(760)743-7744 |
| xxx@xxx.xxx |
| Storage Environment Temperature | Between 0 and 74 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816594020276 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-06-22 |
| 00816594020375 | ACCOLADE,PV,YELLOW,3GM |
| 00816594020368 | ACCOLADE,PV,XLUCENT,5GM |
| 00816594020351 | ACCOLADE,PV,WHITE,OPAQUER,3GM |
| 00816594020344 | ACCOLADE,PV,TRY-IN,YELLOW,3GM |
| 00816594020337 | ACCOLADE,PV,TRY-IN,XTRA LT,3GM |
| 00816594020320 | ACCOLADE,PV,TRY-IN,WHT,OPQ,3GM |
| 00816594020313 | ACCOLADE,PV,TRY-IN,TRANSL.5GM |
| 00816594020306 | ACCOLADE,PV,TRY-IN,LIGHT,3GM |
| 00816594020290 | ACCOLADE,PV,TRY-IN,BROWN,3GM |
| 00816594020283 | ACCOLADE,PV,TRY-IN KIT |
| 00816594020276 | ACCOLADE,PV,LIGHT,3GM |
| 00816594020269 | ACCOLADE,PV,EXTRA,LIGHT,3GM |
| 00816594020252 | ACCOLADE,PV,BROWN,3GM |