| Primary Device ID | 00190746077005 |
| NIH Device Record Key | 9777f0eb-185a-4161-a320-79afa2e97fc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stainless Steel Multi-Strand |
| Version Model Number | 857-215NW |
| Catalog Number | 857-215NW |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 and 38 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746077005 [Primary] |
| DZC | WIRE, 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 | 2019-07-09 |
| Device Publish Date | 2018-01-18 |
| 00190746077135 | WIRE SS FORM I UNIV 016X016 STREIGHT IND 10/PK |
| 00190746077128 | WIRE SS FORM I UNIV 021X025 STREIGHT IND 10/PK |
| 00190746077111 | WIRE SS FORM I UNIV 019X025 STREIGHT IND 10/PK |
| 00190746077104 | WIRE SS FORM I UNIV 018X025 STREIGHT IND 10/PK |
| 00190746077098 | WIRE SS FORM I UNIV 017X025 STREIGHT IND 10/PK |
| 00190746077081 | WIRE SS FORM I UNIV 016X022 STREIGHT IND 10/PK |
| 00190746077074 | WIRE SS CO-AX FORM I UNIV 0215 IND 10/PK |
| 00190746077067 | WIRE SS CO-AX FORM I UNIV 0195 IND 10/PK |
| 00190746077050 | WIRE SS CO-AX FORM I UNIV 0175 IND 10/PK |
| 00190746077043 | WIRE SS CO-AX FORM I UNIV 015 IND 10/PK |
| 00190746077036 | WIRE SS TWIST FORM I UNIV 0215 IND 10/PK |
| 00190746077029 | WIRE SS TWIST FORM I UNIV 0195 IND 10/PK |
| 00190746077012 | WIRE SS TWIST FORM I UNIV 0175 IND 10/PK |
| 00190746077005 | WIRE SS TWIST FORM I UNIV 015 IND 10/PK |
| 00190746073113 | WIRE SS CO-AX UNIV 0215 FORM I 10/PKG |
| 00190746073106 | WIRE SS CO-AX UNIV 0195 FORM I 10/PKG |
| 00190746073090 | WIRE SS CO-AX UNIV 0175 FORM I 10/PKG |
| 00190746073083 | WIRE SS CO-AX UNIV 015 FORM I 10/PKG |
| 00190746056406 | WIRE FLATTENED MULTISTRAND SPOOL 010X032 (60 IN LENGTH) |
| 00190746056390 | WIRE FLATTENED MULTISTRAND SPOOL 010X029 (60 IN LENGTH) |
| 00190746056383 | WIRE FLATTENED MULTISTRAND STRAIGHT LENGTH 010X032 (6 IN LENGTH) |
| 00190746056376 | WIRE FLATTENED MULTISTRAND STRAIGHT LENGTH 010X029 (6 IN LENGTH) |
| 00190746055669 | WIRE CO-AX SPOOL 0215 30 FEET |
| 00190746055652 | WIRE CO-AX SPOOL 0195 30 FEET |
| 00190746055645 | WIRE CO-AX SPOOL 0175 30 FEET |
| 00190746055638 | WIRE CO-AX SPOOL 015 30 FEET |
| 00190746049538 | WIRE SS CO-AX STRAIGHT LENGTH 0215 14" 10/PKG |
| 00190746049521 | WIRE SS CO-AX STRAIGHT LENGTH 0195 14" 10/PKG |
| 00190746049514 | WIRE SS CO-AX STRAIGHT LENGTH 0175 14" 10/PKG |
| 00190746049507 | WIRE SS CO-AX STRAIGHT LENGTH 015 14" 10/PKG |
| 00190746049491 | WIRE SS TWIST STRAIGHT LENGTH 0215 15" 10/PKG |
| 00190746049484 | WIRE SS TWIST STRAIGHT LENGTH 0195 15" 10/PKG |
| 00190746049477 | WIRE SS TWIST STRAIGHT LENGTH 0175 15" 10/PKG |
| 00190746049460 | WIRE SS TWIST STRAIGHT LENGTH 015 15" 10/PKG |
| 00190746060472 | WIRE SS CO-AX STRAIGHT LENGTH 0215 14in 10/PK |
| 00190746060458 | WIRE SS CO-AX STRAIGHT LENGTH 0195 14in 10/PK |
| 00190746060441 | WIRE SS CO-AX STRAIGHT LENGTH 0175 14in 10/PK |
| 00190746060434 | WIRE SS CO-AX STRAIGHT LENGTH 015 14in 10/PK |
| 00190746060410 | WIRE SS TWIST STRAIGHT LENGTH 0215 15in 10/PK |
| 00190746060403 | WIRE SS TWIST STRAIGHT LENGTH 0195 15in 10/PK |
| 00190746060397 | WIRE SS TWIST STRAIGHT LENGTH 0175 15in 10/PK |
| 00190746060373 | WIRE SS TWIST STRAIGHT LENGTH 015 15in 10/PK |
| 00190746060526 | WIRE SS CO-AX SPOOL 0215 30ft |
| 00190746060519 | WIRE SS CO-AX SPOOL 0195 30ft |
| 00190746060496 | WIRE SS CO-AX SPOOL 0175 30ft |
| 00190746060489 | WIRE SS CO-AX SPOOL 015 30ft |