| Primary Device ID | 00190746134098 |
| NIH Device Record Key | 69f80474-4625-409f-b55c-45767031adcc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eagle No Drift |
| Version Model Number | 001-943 |
| Catalog Number | 001-943 |
| Company DUNS | 044668515 |
| Company Name | AMERICAN ORTHODONTICS 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 | 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(800)558-7687 |
| info@americanortho.com |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746134098 [Primary] |
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, 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 | 2018-08-17 |
| Device Publish Date | 2018-07-17 |
| 00190746134098 | EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG |
| 00190746134081 | EAGLE NO DRIFT ADHESIVE CARPULE KIT |
| 00190746007743 | EAGLE NO DRIFT MODIFIED SEALANT 6 GMS |
| 00190746007682 | EAGLE NO DRIFT ADHESIVE CARPULE KIT W/ FLUORSURE SEALANT |
| 00190746007668 | EAGLE NO DRIFT ADHESIVE CARPULE-TRANSPARENT 20/PKG |
| 00190746007651 | EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG |
| 00190746000027 | EAGLE NO DRIFT ADHESIVE CARPULE KIT |