Home GUDID 00763000647094
Avalus Ultra™
Primary DI 00763000647094
Brand Avalus Ultra™
Company MEDTRONIC, INC.
Model 7400SU
Device description AVALUSTM ULTRA 7400SU SIZERS
Published 2024-05-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name DTI SIZER, HEART-VALVE, PROSTHESIS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTI Sizer, Heart-Valve, Prosthesis Cardiovascular 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00763000647094 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00763000647094 00763000647094 763000647094 0763000647094
GMDN Terms# Term, Definition table Term Definition Aortic heart valve bioprosthesis A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 006261481 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05415067052964 Epic™ ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067052971 Epic™ ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067052988 Epic™ ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067054197 NA ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067054203 NA ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067054210 NA ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067054227 NA ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067054234 NA ST. JUDE MEDICAL, INC. DTI 2026-07-08 05415067054241 NA ST. JUDE MEDICAL, INC. DTI 2026-07-08 00763000990657 Mosaic Neo™ S310MNH MEDTRONIC, INC. DTI 2026-04-13 00763000990664 Mosaic Neo™ S310MNS MEDTRONIC, INC. DTI 2026-04-13 00690103019643 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019650 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019674 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019698 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019704 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019711 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019728 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019735 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019742 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019759 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019766 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019773 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019780 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019797 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019803 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019810 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019827 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019834 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06 00690103019841 HEART VALVE ACCESSORY Edwards Lifesciences LLC DTI 2026-04-06