| Primary Device ID | 00190746006531 |
| NIH Device Record Key | d3034927-d0c7-4ce6-95cb-2ac7afec7b9f |
| Commercial Distribution Discontinuation | 2017-02-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Virage Ceramic Brackets |
| Version Model Number | 002-1033BV |
| Catalog Number | 002-1033BV |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746006531 [Primary] |
| NJM | Bracket, ceramic, orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-09 |
| 00190746007644 | COSMETIC VIRAGE UL LATERAL 022 T+14 A+8 R=0 |
| 00190746007637 | COSMETIC VIRAGE UR LATERAL 022 T+14 A+8 R=0 |
| 00190746007620 | COSMETIC VIRAGE UL CENTRAL 022 T+22 A+5 R=0 |
| 00190746007613 | COSMETIC VIRAGE UR CENTRAL 022 T+22 A+5 R=0 |
| 00190746007606 | COSMETIC VIRAGE LL 2ND BICUSPID 018 T-17 A=0 R=0 W/HK DIST |
| 00190746007590 | COSMETIC VIRAGE LR 2ND BICUSPID 018 T-17 A=0 R=0 W/HK DIST |
| 00190746007583 | COSMETIC VIRAGE MAND 2ND BICUSPID 018 T-17 A=0 R=0 |
| 00190746007576 | COSMETIC VIRAGE LL 1ST BICUSPID 018 T-11 A=0 R=0 W/HK DIST |
| 00190746007569 | COSMETIC VIRAGE LR 1ST BICUSPID 018 T-11 A=0 R=0 W/HK DIST |
| 00190746007552 | COSMETIC VIRAGE MAND 1ST BICUSPID 018 T-11 A=0 R=0 |
| 00190746007545 | COSMETIC VIRAGE LL CUSPID 018 T+7 A+5 R=0 |
| 00190746007538 | COSMETIC VIRAGE LL CUSPID 018 T+7 A+5 R=0 W/HK DIST |
| 00190746007521 | COSMETIC VIRAGE LR CUSPID 018 T+7 A+5 R=0 |
| 00190746007514 | COSMETIC VIRAGE LR CUSPID 018 T+7 A+5 R=0 W/HK DIST |
| 00190746007507 | COSMETIC VIRAGE MAND ANTERIOR 018 T=0 A=0 R=0 |
| 00190746007491 | COSMETIC VIRAGE UL BICUSPID 018 T-7 A=0 R=0 W/HK DIST |
| 00190746007484 | COSMETIC VIRAGE UR BICUSPID 018 T-7 A=0 R=0 W/HK DIST |
| 00190746007477 | COSMETIC VIRAGE MAX BICUSPID 018 T-7 A=0 R=0 |
| 00190746007460 | COSMETIC VIRAGE UL CUSPID 018 T+7 A+5 R=0 |
| 00190746007453 | COSMETIC VIRAGE UL CUSPID 018 T+7 A+5 R=0 W/HK DIST |
| 00190746007446 | COSMETIC VIRAGE UR CUSPID 018 T+7 A+5 R=0 |
| 00190746007439 | COSMETIC VIRAGE UR CUSPID 018 T+7 A+5 R=0 W/HK DIST |
| 00190746007422 | COSMETIC VIRAGE UL LATERAL 018 T+14 A+8 R=0 |
| 00190746007415 | COSMETIC VIRAGE UR LATERAL 018 T+14 A+8 R=0 |
| 00190746007408 | COSMETIC VIRAGE UL CENTRAL 018 T+22 A+5 R=0 |
| 00190746007392 | COSMETIC VIRAGE UR CENTRAL 018 T+22 A+5 R=0 |
| 00190746007385 | COSMETIC VIRAGE UL CUSPID 022 T-7 A+8 R=0 |
| 00190746007378 | COSMETIC VIRAGE UL CUSPID 022 T-7 A+8 R=0 W/HK DIST |
| 00190746007361 | COSMETIC VIRAGE UR CUSPID 022 T-7 A+8 R=0 |
| 00190746007354 | COSMETIC VIRAGE UR CUSPID 022 T-7 A+8 R=0 W/HK DIST |
| 00190746007347 | COSMETIC VIRAGE UL CUSPID 018 T-7 A+8 R=0 |
| 00190746007330 | COSMETIC VIRAGE UL CUSPID 018 T-7 A+8 R=0 W/HK DIST |
| 00190746007323 | COSMETIC VIRAGE UR CUSPID 018 T-7 A+8 R=0 |
| 00190746007316 | COSMETIC VIRAGE UR CUSPID 018 T-7 A+8 R=0 W/HK DIST |
| 00190746007309 | COSMETIC VIRAGE LL CUSPID 022 T-5 A+5 R5M W/HK DIST |
| 00190746007293 | COSMETIC VIRAGE LR CUSPID 022 T-5 A+5 R5M W/HK DIST |
| 00190746007286 | COSMETIC VIRAGE MAND ANTERIOR 022 T+3 A=0 R=0 |
| 00190746007279 | COSMETIC VIRAGE UL CUSPID 022 T+8 A+9 R5M W/HK DIST |
| 00190746007262 | COSMETIC VIRAGE UR CUSPID 022 T+8 A+9 R5M W/HK DIST |
| 00190746007255 | COSMETIC VIRAGE UL LATERAL 022 T+18 A+6 R=0 |
| 00190746007248 | COSMETIC VIRAGE UR LATERAL 022 T+18 A+6 R=0 |
| 00190746007231 | COSMETIC VIRAGE UL CENTRAL 022 T+24 A+3 R=0 |
| 00190746007224 | COSMETIC VIRAGE UR CENTRAL 022 T+24 A+3 R=0 |
| 00190746007217 | COSMETIC VIRAGE LL CUSPID 018 T-5 A+5 R5M W/HK DIST |
| 00190746007200 | COSMETIC VIRAGE LR CUSPID 018 T-5 A+5 R5M W/HK DIST |
| 00190746007194 | COSMETIC VIRAGE MAND ANTERIOR 018 T+3 A=0 R=0 |
| 00190746007187 | COSMETIC VIRAGE UL CUSPID 018 T+8 A+9 R5M W/HK DIST |
| 00190746007170 | COSMETIC VIRAGE UR CUSPID 018 T+8 A+9 R5M W/HK DIST |
| 00190746007163 | COSMETIC VIRAGE UL LATERAL 018 T+18 A+6 R=0 |
| 00190746007156 | COSMETIC VIRAGE UR LATERAL 018 T+18 A+6 R=0 |