Identity
- Trade Name
- WiSE CRT System FDA UDI
- Generic Name
- Left-ventricular wireless pacing system transducer/electrode FDA UDI
- Device Name
- Delivery Sheath FDA UDI
- Model / Reference
- 2000 FDA UDI
- Description
- Delivery Sheath FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859244007067 FDA UDI
- PMA Number
- P240028 FDA UDI
- FDA Product Code
- SEG FDA UDI
- GMDN Term
- Left-ventricular wireless pacing system transducer/electrode 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
Category: Left-ventricular wireless pacing system transducer/electrode
WiSE CRT System by EBR Systems, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Left-ventricular wireless pacing system transducer/electrode.
- WiSE CRT System — EBR Systems, Inc. · Class III
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 de5c99c3-43b0-435b-b79d-c9edc8658fba 36 fields · synced Jun 8, 2026