| Primary Device ID | 00190746150685 |
| NIH Device Record Key | 75780812-665c-4364-81e0-8c6b04a4aed0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 300 Series Facebow |
| Version Model Number | 852-345 |
| Catalog Number | 852-345 |
| Company DUNS | 044668515 |
| Company Name | AMERICAN ORTHODONTICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746150685 [Primary] |
| KCR | FACEBOW |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-08 |
| Device Publish Date | 2019-09-30 |
| 00190746150760 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 6 118MM |
| 00190746150753 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 5 111MM |
| 00190746150746 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 4 104MM |
| 00190746150739 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 3 97MM |
| 00190746150722 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 2 90MM |
| 00190746150715 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 5 111MM |
| 00190746150708 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 4 104MM |
| 00190746150692 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 3 97MM |
| 00190746150685 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 2 90MM |
| 00190746150678 | FACEBOW LOOP STYLE 051 SIZE 6 118MM |
| 00190746150661 | FACEBOW LOOP STYLE 051 SIZE 5 111MM |
| 00190746150654 | FACEBOW LOOP STYLE 051 SIZE 4 104MM |
| 00190746150647 | FACEBOW LOOP STYLE 051 SIZE 3 97MM |
| 00190746150630 | FACEBOW LOOP STYLE 051 SIZE 2 90MM |
| 00190746150616 | FACEBOW SHORT OUTER BOW 045 |
| 00190746150609 | FACEBOW STANDARD OUTER BOW 045 |
| 00190746150593 | FACEBOW LOOP STYLE 045 SIZE 6 118MM |
| 00190746150586 | FACEBOW LOOP STYLE 045 SIZE 5 111MM |
| 00190746150579 | FACEBOW LOOP STYLE 045 SIZE 4 104MM |
| 00190746150562 | FACEBOW LOOP STYLE 045 SIZE 39 7MM |
| 00190746150555 | FACEBOW LOOP STYLE 045 SIZE 2 90MM |
| 00190746150623 | FACEBOW LONG OUTER BOW 045 |