DEVICE: HexaGen™ RF Generator (00763000871864)

Device Identifier (DI) Information

HexaGen™ RF Generator
AFR-00004
In Commercial Distribution

MEDTRONIC, INC.
00763000871864
GS1

1
006261481 *Terms of Use
GENERATOR AFR-00004 HEXAGEN RF US
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60784 Cardiac radio-frequency ablation system generator
An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QZI Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
OAE Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P240013 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

bc6d53e7-0928-49df-a103-ecd5689e3e4d
November 12, 2024
1
November 04, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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