Primary Device ID | 00840097509785 |
NIH Device Record Key | ff9c25e9-cb89-453d-9733-b120ea32aa51 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | restor3d Total Talus Replacement |
Version Model Number | 1102-05 |
Company DUNS | 080819836 |
Company Name | Restor3d, 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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840097509785 [Primary] |
QNN | Prosthesis, Total Talus Replacement, Metal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
[00840097509785]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-25 |
Device Publish Date | 2024-03-15 |
00840097509907 | Impactor, Contoured |
00840097509891 | Impactor, Flat |
00840097509884 | Trial, Total Talus, 110% |
00840097509877 | Trial, Total Talus, 105% |
00840097509860 | Trial, Total Talus, 100% |
00840097509853 | Trial, Total Talus, 95% |
00840097509846 | Trial, Total Talus, 90% |
00840097509839 | Total Talus, With Suture Hole, 110% |
00840097509822 | Total Talus, With Suture Hole, 105% |
00840097509815 | Total Talus, With Suture Hole, 100% |
00840097509808 | Total Talus, With Suture Hole, 95% |
00840097509792 | Total Talus, With Suture Hole, 90% |
00840097509785 | Total Talus, No Suture Hole, 110% |
00840097509778 | Total Talus, No Suture Hole, 105% |
00840097509761 | Total Talus, No Suture Hole, 100% |
00840097509754 | Total Talus, No Suture Hole, 95% |
00840097509747 | Total Talus, No Suture Hole, 90% |