| Primary Device ID | 00190746075094 |
| NIH Device Record Key | 3148ecf9-2c6e-4de5-9ee3-67f49d63f962 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intraoral Expansion Screws |
| Version Model Number | 855-342 |
| Catalog Number | 855-342 |
| 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 | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746075094 [Primary] |
| DYJ | Retainer, Screw Expansion, 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 | 2019-10-16 |
| Device Publish Date | 2019-04-16 |
| 00190746075094 | FIXED FUNCT EXPANSION SCREW RAPID (13MM EXPANSION) |
| 00190746075070 | FIXED FUNCT EXPANSION SCREW RAPID (9MM EXPANSION) |
| 00190746074479 | FIXED FUNCT EXPANSION SCREW KEY 25/PKG |
| 00190746074462 | FIXED FUNCT EXPANSION SCREW MEDIUM 14MM (9MM EXPANSION) 5/PKG |
| 00190746074455 | FIXED FUNCT EXPANSION SCREW MICRO 10MM (6MM EXPANSION) 5/PKG |
| 00190746074448 | FIXED FUNCT EXPANSION SCREW MEDIUM 11MM (7MM EXPANSION) 5/PKG |
| 00190746074431 | FIXED FUNCT EXPANSION SCREW STANDARD 14MM (9MM EXPANSION) 5/PKG |
| 00190746074417 | FIXED FUNCT EXPANSION SCREW RAPID PALATAL 15MM (11MM EXPANSION) |
| 00190746074400 | FIXED FUNCT EXPANSION SCREW RAPID PALATAL 14MM (9MM EXPANSION) |
| 00190746074387 | FIXED FUNCT EXPANSION SCREW RAPID PALATAL 12MM (8MM EXPANSION) |
| 00190746074370 | FIXED FUNCT EXPANSION SCREW RAPID PALATAL 18MM (13MM EXPANSION) |
| 00190746074486 | EXPANSION SCREW SMART SWIVEL KEY 10/PK |
| 00190746074424 | MINI EXPANSION SCREW RAPID PALATAL 16MM (11MM EXPANSION) |
| 00190746074394 | MINI EXPANSION SCREW RAPID PALATAL 13MM (8MM EXPANSION) |