Identity
- Trade Name
- Avalus Ultra™ EUDAMEDFDA UDI
- Generic Name
- Heart valve annulus sizer, reusable FDA UDI
- Device Name
- Avalus Ultra Sizers EUDAMEDAVALUSTM ULTRA 7400SU SIZERS FDA UDI
- Model / Reference
- 7400SU EUDAMEDFDA UDI
- Description
- AVALUSTM ULTRA 7400SU SIZERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000647094 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00026938T EUDAMED
- FDA Product Code
- DTI FDA UDI
- EMDN Code
- P07038001 HEART VALVE IMPLANT SIZERS EUDAMED
- GMDN Term
- Heart valve annulus sizer, reusable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass I FDA UDI
- Regulation Number
- 870.3945 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Heart valve annulus sizer, reusable
Avalus Ultra™ by Medtronic, Inc. — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve annulus sizer, reusable.
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- PERCEVAL S — CORCYM SRL · Class I
- Tailor™ & Attune™ — ST. JUDE MEDICAL, INC. · Class I
- CARBOMEDICS PROSTHETIC HEART VALVES — CORCYM SRL · Class I
- Trifecta™ — ST. JUDE MEDICAL, INC. · Class I
- On-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763000B00026938T | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
- EUDAMED SRN
- US-MF-000019977
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (2)
- EUDAMED caa51399-603b-43f8-a53e-11e70a437788 61 fields · synced Jun 6, 2026
- FDA UDI cc847ce4-b11e-4a04-9c7d-9342d19a8c3f 34 fields · synced May 30, 2026