Identity
- Trade Name
- HexaGen™ RF Generator FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Device Name
- RF GEN AFR-00004 HEXAGEN US PLX FDA UDI
- Model / Reference
- AFR-00004 FDA UDI
- Description
- RF GEN AFR-00004 HEXAGEN US PLX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000998301 FDA UDI
- PMA Number
- P240013 FDA UDI
- FDA Product Code
- QZI FDA UDIOAE FDA UDIOAD FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation 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 radio-frequency ablation system generator
HexaGen™ RF Generator by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system generator.
- nContact RF Generator — ATRICURE, INC. · Class II
- INTELLAGEN™ Remote Control — Stockert GmbH · Class III
- Isolator Surgical Ablation System — ATRICURE, INC. · Class II
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
- AtriCure Isolator Synergy EnCompass Clamp and Guide System — ATRICURE, INC. · Class II
- Subtle Cannula with Guide — ATRICURE, INC. · Class I
- Synergy™ Ablation System — ATRICURE, INC. · Class III
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
Cleared under the same submission
P240013 also covers:
- HexaFlow™ Irrigation Pump — MEDTRONIC, INC.
- HexaFlow™ Irrigation Pump — MEDTRONIC, INC.
- HexaGen™ RF Generator — MEDTRONIC, INC.
- HexaPulse™ PF Generator — MEDTRONIC, INC.
- HexaPulse™ PF Generator — MEDTRONIC, INC.
- Sphere-9™ — MEDTRONIC, INC.
- Sphere-9™ Catheter — MEDTRONIC, INC.
- Sphere-9™ Catheter — MEDTRONIC, INC.
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 2001ff50-d549-4a33-9861-50c87227f351 35 fields · synced Jun 8, 2026