DEVICE: INTELLAGEN™ RF Generator (04260166374063)
Device Identifier (DI) Information
INTELLAGEN™ RF Generator
20404
In Commercial Distribution
M004GEN100204010
Stockert GmbH
20404
In Commercial Distribution
M004GEN100204010
Stockert GmbH
only commercialized as part of the kit
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LPB | Cardiac Ablation Percutaneous Catheter |
OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
37041d24-29b8-486d-b2ae-595d664ceda7
September 09, 2024
1
September 01, 2024
September 09, 2024
1
September 01, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1-888-272-1001
CETechSupportUSA@bsci.com
CETechSupportUSA@bsci.com