| Primary Device ID | 00190746008108 |
| NIH Device Record Key | 4c0f585c-570a-4f54-8422-25a527b7d5b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safety Release Spring Module |
| Version Model Number | 852-825 |
| Catalog Number | 852-825 |
| 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 | 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 | 00190746008108 [Primary] |
| DZB | Headgear, Extraoral, 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 | 2016-12-07 |
| 00190746008108 | SAFETY RELEASE SPRING MODULE - MEDIUM/20 OZ WHITE/WHITE 10/PKG |
| 00190746008092 | SAFETY RELEASE SPRING MODULE - HEAVY/23 OZ BLUE 10/PKG |
| 00190746008085 | SAFETY RELEASE SPRING MODULE - MEDIUM/20 OZ WHITE 10/PKG |
| 00190746073649 | SAFETY RELEASE SPRING MODULE - LIGHT/16 OZ CLEAR 10/PK |