| Primary Device ID | 00190746133794 |
| NIH Device Record Key | 5f41b954-3fa4-42d5-b06f-48f6b30dd9fc |
| Commercial Distribution Discontinuation | 2020-03-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Elastic Lugs |
| Version Model Number | 852-192 |
| Catalog Number | 852-192 |
| 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 | 00190746133794 [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 |
| 00190746133794 | LINGUAL ELASTIC LUG FLAT |
| 00190746133787 | LINGUAL ELASTIC LUG CURVED |
| 00190746133619 | DB LINGUAL ELASTIC LUG FLAT PAD 10/PKG |
| 00190746133602 | DB LINGUAL ELASTIC LUG CURVED PAD 10/PKG |
| 00190746133251 | LINGUAL ELASTIC LUG FLAT 100/PKG |
| 00190746133244 | LINGUAL ELASTIC LUG CURVED PK/100 |
| 00190746155055 | LINGUAL ELASTIC LUG FLAT |
| 00190746155048 | LINGUAL ELASTIC LUG CURVED |