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WiSE CRT System

FDA UDI

Class III (US FDA UDI)

by EBR Systems, Inc.

Identity

Trade Name
WiSE CRT System FDA UDI
Generic Name
Implantable pacemaker battery FDA UDI
Device Name
Battery FDA UDI
Model / Reference
3100 FDA UDI
Description
Battery FDA UDI

Identifiers

Primary DI / UDI-DI
00859244007029 FDA UDI
PMA Number
P240028 FDA UDI
FDA Product Code
SEG FDA UDI
GMDN Term
Implantable pacemaker battery 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
MRI Safety
MR Conditional FDA UDI

Category: Implantable pacemaker battery

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

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Manufacturer

Manufacturer
EBR Systems, Inc.

Sources (1)

  • FDA UDI f2752c2a-0711-4138-9139-e225c7590044 36 fields · synced May 30, 2026