Identity
- Trade Name
- Evera MRI™ S DR SureScan® FDA UDI
- Generic Name
- Dual-chamber implantable defibrillator FDA UDI
- Device Name
- ICD DDMC3D4 EVERA MRI DR S DF4 US FDA UDI
- Model / Reference
- DDMC3D4 FDA UDI
- Description
- ICD DDMC3D4 EVERA MRI DR S DF4 US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169314139 FDA UDI
- FDA Product Code
- LWS FDA UDINVZ FDA UDI
- GMDN Term
- Dual-chamber implantable defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Evera MRI™ S DR SureScan® by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI d0ddddc5-71c4-4d74-8fea-5f8f3a2f9ac5 36 fields · synced May 31, 2026