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HexaPulse™ PF Generator

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
HexaPulse™ PF Generator FDA UDI
Generic Name
Cardiac irreversible electroporation system generator FDA UDI
Device Name
GENERATOR AFR-00008 HEXAPULSE PF US FDA UDI
Model / Reference
AFR-00008 FDA UDI
Description
GENERATOR AFR-00008 HEXAPULSE PF US FDA UDI

Identifiers

Primary DI / UDI-DI
00763000871925 FDA UDI
PMA Number
P240013 FDA UDI
FDA Product Code
OAE FDA UDI
QZI FDA UDI
OAD FDA UDI
GMDN Term
Cardiac irreversible electroporation system generator FDA UDI

Classification

Device Class
Class III 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

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

Category: Cardiac irreversible electroporation system generator

HexaPulse™ PF Generator by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac irreversible electroporation system generator.

Cleared under the same submission

P240013 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 824ee69a-e8a4-46ab-ac2a-68f770c2d103 35 fields · synced May 30, 2026