| Primary Device ID | 00816594021624 |
| NIH Device Record Key | 97389920-5b00-466a-ad63-d947e672554c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MICROPROPHY |
| Version Model Number | 201684-00 |
| Catalog Number | 201684-00 |
| Company DUNS | 601302743 |
| Company Name | DANVILLE MATERIALS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816594021624 [Primary] |
| EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816594021624]
Moist Heat or Steam Sterilization
[00816594021624]
Moist Heat or Steam Sterilization
[00816594021624]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-06-22 |
| 00816594021600 - MICROPRIME | 2019-02-07 MICROPRIME B,10ML,FA |
| 00816594021617 - MICROPRIME | 2019-02-07 MICROPRIME G,UD,50 |
| 00816594020092 - ACCOLADE OP | 2018-03-29 ACCOLADE,OP,WHITE,2GM,FA |
| 00816594020108 - ACCOLADE | 2018-03-29 ACCOLADE,A0,5GM |
| 00816594020115 - ACCOLADE | 2018-03-29 ACCOLADE,A00op,5GM |
| 00816594020122 - ACCOLADE | 2018-03-29 ACCOLADE,A1,5GM |
| 00816594020139 - ACCOLADE | 2018-03-29 ACCOLADE,A2,5GM |
| 00816594020146 - ACCOLADE | 2018-03-29 ACCOLADE,A3,5GM FA |