| Primary Device ID | 00190746125584 |
| NIH Device Record Key | 9758fbe7-0a1c-44d5-9034-b298a8a4d0ac |
| Commercial Distribution Discontinuation | 2020-03-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ball Hooks |
| Version Model Number | 852-183 |
| Catalog Number | 852-183 |
| 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 | 00190746125584 [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 |
| 00190746133770 | WELD LINGUAL BALL HOOK STEP-UP |
| 00190746133732 | LINUGAL BALL HOOK 90 DEGREE BEND 4.5MM |
| 00190746132926 | WELD LINGUAL BALL HOOK SHORT OFFSET 100/PK |
| 00190746132919 | WELD LINGUAL BALL HOOK SHORT W/LONG OFFSET 100/PK |
| 00190746128103 | WELD LINGUAL BALL HOOK .050 STRAIGHT FLAT 100/PK |
| 00190746125683 | WELD LINGUAL BALL HOOK STEP-UP |
| 00190746125584 | WELD LINGUAL BALL HOOK SHORT OFFSET |
| 00190746125577 | WELD LINGUAL BALL HOOK SHORT W/LONG OFFSET |
| 00190746125508 | WELD LINGUAL BALL HOOK .050 STRAIGHT FLAT |
| 00190746155031 | WELD LINGUAL BALL HOOK SHORT OFFSET |
| 00190746155024 | WELD LINGUAL BALL HOOK SHORT W/LONG OFFSET 100/PK |
| 00190746155017 | WELD LINGUAL BALL HOOK STEP-UP |
| 00190746154997 | WELD LINGUAL BALL HOOK .050 STRAIGHT FLAT 100/PK |
| 00190746154980 | WELD LINGUAL BALL HOOK STEP-UP |
| 00190746154966 | WELD LINGUAL BALL HOOK .050 STRAIGHT FLAT |