| Primary Device ID | 00190746072413 | 
| NIH Device Record Key | b93ab465-6b56-4337-9e54-d5c446af9c35 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | NT3 | 
| Version Model Number | 857-3U-1925H | 
| Catalog Number | 857-3U-1925H | 
| 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 | true | 
| 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 | |
| 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 | |
| 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 | |
| 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 | 00190746072413 [Primary] | 
| DZC | WIRE, ORTHODONTIC | 
| 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 | 2017-10-25 | 
| 00190746076718 | WIRE NITI VLP UNIV 021X025 IND 10/PK | 
| 00190746076701 | WIRE NITI VLP UNIV 021X025 10/PK | 
| 00190746076695 | WIRE NITI VLP UNIV 020 IND 10/PK | 
| 00190746076688 | WIRE NITI VLP UNIV 020 10/PK | 
| 00190746076671 | WIRE NITI VLP UNIV 016X022 IND 10/PK | 
| 00190746076664 | WIRE NITI VLP UNIV 016X022 10/PK | 
| 00190746076657 | WIRE NITI VLP UNIV 016X016 IND 10/PK | 
| 00190746076640 | WIRE NITI VLP UNIV 016X016 10/PK | 
| 00190746076633 | WIRE NITI FORM I LOWER 021X025 T=20 28MM IND 10/PK | 
| 00190746076626 | WIRE NITI FORM I LOWER 019X025 T=20 28MM IND 10/PK | 
| 00190746076619 | WIRE NITI FORM I LOWER 018X025 T=20 28MM IND 10/PK | 
| 00190746076602 | WIRE NITI FORM I LOWER 016X022 T=20 28MM IND 10/PK | 
| 00190746076596 | WIRE NITI FORM I LOWER 017X025 T=20 28MM IND 10/PK | 
| 00190746076589 | WIRE NITI FORM I UPPER 021X025 T=20 38MM IND 10/PK | 
| 00190746076572 | WIRE NITI FORM I UPPER 021X025 T=20 34MM IND 10/PK | 
| 00190746076565 | WIRE NITI FORM I UPPER 019X025 T=20 38MM IND 10/PK | 
| 00190746076558 | WIRE NITI FORM I UPPER 019X025 T=20 34MM IND 10/PK | 
| 00190746076541 | WIRE NITI FORM I UPPER 018X025 T=20 38MM IND 10/PK | 
| 00190746076534 | WIRE NITI FORM I UPPER 018X025 T=20 34MM IND 10/PK | 
| 00190746076527 | WIRE NITI FORM I UPPER 016X022 T=20 38MM IND 10/PK | 
| 00190746076510 | WIRE NITI FORM I UPPER 016X022 T=20 34MM IND 10/PK | 
| 00190746076503 | WIRE NITI FORM I UPPER 017X025 T=20 38MM IND 10/PK | 
| 00190746076497 | WIRE NITI FORM I UPPER 017X025 T=20 34MM IND 10/PK | 
| 00190746076480 | WIRE NITI FORM III UPPER 014X025 IND 10/PK | 
| 00190746076473 | WIRE NITI FORM III UPPER 014X025 10/PK | 
| 00190746076466 | WIRE NITI FORM III LOWER 014X025 IND 10/PK | 
| 00190746076459 | WIRE NITI FORM III LOWER 014X025 10/PK | 
| 00190746076442 | WIRE NITI FORM I UPPER 020X020 IND 10/PK | 
| 00190746076435 | WIRE NITI FORM I UPPER 020X020 10/PK | 
| 00190746076428 | WIRE NITI FORM I LOWER 020X020 IND 10/PK | 
| 00190746076411 | WIRE NITI FORM I LOWER 020X020 10/PK | 
| 00190746072512 | WIRE NITI FORM III LOWER 021X025 100/PK | 
| 00190746072505 | WIRE NITI FORM III LOWER 020X020 100/PK | 
| 00190746072499 | WIRE NITI FORM III LOWER 019X025 100/PK | 
| 00190746072482 | WIRE NITI FORM III LOWER 018X025 100/PK | 
| 00190746072475 | WIRE NITI FORM III LOWER 018X018 100/PK | 
| 00190746072468 | WIRE NITI FORM III LOWER 017X025 100/PK | 
| 00190746072451 | WIRE NITI FORM III LOWER 016X022 100/PK | 
| 00190746072444 | WIRE NITI FORM III LOWER 016X016 100/PK | 
| 00190746072437 | WIRE NITI FORM III UPPER 021X025 100/PK | 
| 00190746072420 | WIRE NITI FORM III UPPER 020X020 100/PK | 
| 00190746072413 | WIRE NITI FORM III UPPER 019X025 100/PK | 
| 00190746072406 | WIRE NITI FORM III UPPER 018X025 100/PK | 
| 00190746072390 | WIRE NITI FORM III UPPER 018X018 100/PK | 
| 00190746072383 | WIRE NITI FORM III UPPER 017X025 100/PK | 
| 00190746072376 | WIRE NITI FORM III UPPER 016X022 100/PK | 
| 00190746072369 | WIRE NITI FORM III UPPER 016X016 100/PK | 
| 00190746072352 | WIRE NITI FORM III LOWER 020 100/PK | 
| 00190746072345 | WIRE NITI FORM III LOWER 018 100/PK | 
| 00190746072338 | WIRE NITI FORM III LOWER 016 100/PK |