| Primary Device ID | 00848665036183 |
| NIH Device Record Key | 236df2ef-f678-488a-8f8b-f9a85cb85538 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERIMETER CALCANEAL PLATE LEFT, EXTRA SMALL |
| Version Model Number | 3078-010 |
| Company DUNS | 117858154 |
| Company Name | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | 3105339966 |
| regaffairs@aosortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848665036183 [Primary] |
| HRS | Plate, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00848665036183]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-02-19 |
| Device Publish Date | 2020-06-16 |
| 00848665028980 - SEMI-TUBULAR PLATE, 13-HOLE | 2024-11-13 |
| 00848665029000 - SEMI-TUBULAR PLATE, 15-HOLE | 2024-11-13 |
| 00848665029017 - SEMI-TUBULAR PLATE, 17-HOLE | 2024-11-13 |
| 00848665029024 - SEMI-TUBULAR PLATE, 19-HOLE | 2024-11-13 |
| 00848665029031 - SEMI-TUBULAR PLATE, 21-HOLE | 2024-11-13 |
| 00848665029048 - STRAIGHT PLATE, 13-HOLE | 2024-11-13 |
| 00848665029055 - STRAIGHT PLATE, 15-HOLE | 2024-11-13 |
| 00848665029062 - STRAIGHT PLATE, 17-HOLE | 2024-11-13 |