Primary Device ID | 00848665032727 |
NIH Device Record Key | 9b0b8d48-95b6-40d2-a431-90b9ea594e24 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, LARGE |
Version Model Number | 3076-060 |
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 | 00848665032727 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00848665032727]
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 |