| Primary Device ID | 00190746125492 |
| NIH Device Record Key | 2b78f4a3-9165-49db-8766-a04336bc1e9b |
| Commercial Distribution Discontinuation | 2020-03-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Low Profile Cleats |
| Version Model Number | 852-167 |
| Catalog Number | 852-167 |
| 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 | false |
| 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 | 00190746125492 [Primary] |
| ECN | CLAMP, 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 | 2020-03-19 |
| Device Publish Date | 2018-07-05 |
| 00190746133756 | LINGUAL CLEAT CUSPID/BICUSPID |
| 00190746133206 | LINGUAL CLEAT MOLAR LOW PROFILE PK/100 |
| 00190746133190 | LINGUAL CLEAT MOLAR HEAVY DUTY PK/100 |
| 00190746133183 | LINGUAL CLEAT CUSPID/BICUSPID PK/100 |
| 00190746132964 | DB LINGUAL LOW PROFILE CLEAT 10/PKG |
| 00190746125492 | LINGUAL CLEAT MOLAR HEAVY DUTY |
| 00190746114748 | LINGUAL CLEAT MOLAR LOW PROFILE |
| 00190746154973 | LINGUAL CLEAT MOLAR HEAVY DUTY |