| Primary Device ID | 00190746056352 |
| NIH Device Record Key | 645a7630-5329-4061-9212-f889d284dcda |
| Commercial Distribution Discontinuation | 2018-12-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Auxillary |
| Version Model Number | 851-639 |
| Catalog Number | 851-639 |
| 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@americnaortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746056352 [Primary] |
| ECO | Spring, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-18 |
| Device Publish Date | 2017-10-25 |
| 00190746059681 - Luno | 2025-06-24 INSTRUMENT LUNO REPLACEMENT BLADE AND WRENCH FOR 001-017395 |
| 00190746059698 - Luno | 2025-06-24 INSTRUMENT LUNO REPLACEMENT TIPS, SCREW AND WRENCH FOR 001-017405 |
| 00190746067266 - Mini Standard Edgewise | 2025-06-24 DB BKT MINI STANDARD EDGEWISE LOW LOWER ANT 022 T=0 A=0 R=0 |
| 00190746065439 - Beta Titanium Wire | 2025-06-23 WIRE B-TI FORM I UPPER 018X025 10/PK |
| 00190746065446 - Beta Titanium Wire | 2025-06-23 WIRE B-TI FORM I UPPER 018X025 IND 10/PK |
| 00190746065453 - Beta Titanium Wire | 2025-06-23 WIRE B-TI FORM I LOWER 018X025 10/PK |
| 00190746065460 - Beta Titanium Wire | 2025-06-23 WIRE B-TI FORM I LOWER 018X025 IND 10/PK |
| 00190746065514 - LP Low Profile | 2025-06-06 DB TUBE LP UR 1ST MOL 022 NON-CONV T-14 R10D 4.5MM W/HK |