Primary Device ID | 00763000647094 |
NIH Device Record Key | cc847ce4-b11e-4a04-9c7d-9342d19a8c3f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Avalus Ultra™ |
Version Model Number | 7400SU |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
Device Count | 1 |
DM Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000647094 [Primary] |
DTI | SIZER, HEART-VALVE, PROSTHESIS |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-13 |
Device Publish Date | 2024-05-05 |
00763000647094 | AVALUSTM ULTRA 7400SU SIZERS |
00763000647070 | AVALUSTM ULTRA 400U29 29MM VALVE SIZE |
00763000647063 | AVALUSTM ULTRA 400U27 27MM VALVE SIZE |
00763000647056 | AVALUSTM ULTRA 400U25 25MM VALVE SIZE |
00763000647049 | AVALUSTM ULTRA 400U23 23MM VALVE SIZE |
00763000647032 | AVALUSTM ULTRA 400U21 21MM VALVE SIZE |
00763000647025 | AVALUSTM ULTRA 400U19 19MM VALVE SIZE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AVALUS ULTRA 97747710 not registered Live/Pending |
Medtronic, Inc 2023-01-10 |