| Primary Device ID | 00190746146978 |
| NIH Device Record Key | efb3de7f-1c51-4de3-99db-5855ab8a72c1 |
| Commercial Distribution Discontinuation | 2020-03-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Arch Lock |
| Version Model Number | 851-652 |
| Catalog Number | 851-652 |
| 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 | 00190746146978 [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 | 2019-06-24 |
| 00190746146992 | ARCHWIRE LOCK ALLEN WRENCH 5/PKG |
| 00190746146985 | ARCHWIRE LOCK WITH HOOK 10/PKG |
| 00190746146978 | ARCHWIRE LOCK WITHOUT HOOK 10/PKG |
| 00190746146930 | ARCH STOP CAST SPLIT CRIMPABLE 2MM 021X028 10/PKG |
| 00190746146923 | ARCH STOP CAST SPLIT CRIMPABLE 2MM 018X025 10/PKG |
| 00190746146916 | ARCH STOP SPLIT 2MM 030 ROUND 100/PKG |
| 00190746146763 | ARCH STOP CRIMPABLE 2MM W/ ATTACHED WIRE 10/PKG |
| 00190746146756 | ARCH STOP WELDABLE 1.25MM 022X028 100/PKG |
| 00190746146749 | ARCH STOP WELDABLE 1.25MM 018X025 100/PKG |
| 00190746146732 | ARCH STOP SPLIT CRIMPABLE 2MM 022X028 100/PKG |
| 00190746146725 | ARCH STOP SPLIT CRIMPABLE 2MM 018X025 100/PKG |
| 00190746146718 | ARCH STOP WELDABLE WITH FLUTED OPENING 2MM 022X028 100/PKG |
| 00190746146701 | ARCH STOP WELDABLE 2MM 022X028 100/PKG |
| 00190746146695 | ARCH STOP WELDABLE WITH FLUTED OPENING 2MM 018X025 100/PKG |
| 00190746154942 | ARCHWIRE LOCK WITHOUT HOOK 10/PKG |
| 00190746154959 | ARCHWIRE LOCK WITH HOOK 10/PKG |
| 00190746162688 | ARCHWIRE LOCK WITH HOOK KIT OF 10 |
| 00190746162671 | ARCHWIRE LOCK WITHOUT HOOK KIT OF 10 |
| 00190746059377 | ARCHWIRE LOCK ALLEN WRENCH 5/PKG |