Identity
- Trade Name
- Simulus™ FDA UDI
- Generic Name
- Heart valve annulus sizer, reusable FDA UDI
- Device Name
- SIZERS 751PS SIM FLX RNG/BND POLYSULFONE FDA UDI
- Model / Reference
- 751PS FDA UDI
- Description
- SIZERS 751PS SIM FLX RNG/BND POLYSULFONE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169346192 FDA UDI
- FDA Product Code
- DTI FDA UDI
- GMDN Term
- Heart valve annulus sizer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.3945 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Simulus™ by Medtronic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve annulus sizer, reusable.
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- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 34fee875-4fa4-44ee-a1f9-70d49dbfa5c5 34 fields · synced May 31, 2026