Identity
- Trade Name
- WiSE CRT System FDA UDI
- Generic Name
- Left-ventricular wireless pacing system sensor/transmitter FDA UDI
- Device Name
- Transmitter FDA UDI
- Model / Reference
- 4100 FDA UDI
- Description
- Transmitter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859244007005 FDA UDI
- PMA Number
- P240028 FDA UDI
- FDA Product Code
- SEG FDA UDI
- GMDN Term
- Left-ventricular wireless pacing system sensor/transmitter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Left-ventricular wireless pacing system sensor/transmitter
WiSE CRT System by EBR Systems, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P240028 also covers:
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
- EBR Systems, Inc.
Sources (1)
- FDA UDI 129a25ea-9e6a-4f58-89ac-441c6b8eb052 36 fields · synced Jun 8, 2026