| Primary Device ID | 00190746056338 | 
| NIH Device Record Key | 2e763c84-188b-47b9-a53b-486b1b47a600 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Separating Spring | 
| Version Model Number | 353-022C | 
| Catalog Number | 353-022C | 
| 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 | 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 | 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 | |
| Phone | +1(800)558-7687 | 
| info@americanortho.com | |
| Phone | +1(800)558-7687 | 
| info@americanortho.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00190746056338 [Primary] | 
| ECO | Spring, 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 | 2018-04-25 | 
| Device Publish Date | 2017-10-25 | 
| 00190746056345 | SPRING SELF-LOCKING SEPARATING 022 MEDIUM 10/PKG | 
| 00190746056338 | SPRING SELF-LOCKING SEPARATING 022 LONG 10/PKG |