| Primary Device ID | 00816594020467 |
| NIH Device Record Key | d828f41f-bbb5-4f6b-8861-3c42a24143bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCOLADE SRO |
| Version Model Number | 91416 |
| Catalog Number | 91416 |
| 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 | 00816594020467 [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 |
| 00816594020467 | ACCOLADE,SRO,RFL,A5,1GM |
| 00816594020450 | ACCOLADE,SRO,WHITE,OPAQUER,5GM |
| 00816594020443 | ACCOLADE,SRO,WHITE,OPAQUER,1GM |
| 00816594020429 | ACCOLADE,SRO,RFL,A2,1GM |
| 00816594020412 | ACCOLADE,SRO,EXT,LT,1GM,REFILL |
| 00816594020405 | ACCOLADE,SRO,EXL,5GM |
| 00816594020399 | ACCOLADE,SRO,A5,5GM |
| 00816594020382 | ACCOLADE,SRO,A2,5GM |