INTELLAGEN™ RF Generator

Basic Information

• Brand Name: INTELLAGEN™ RF Generator
• Primary DI: 04260166374063
• Version / Model: 20404
• Catalog Number: M004GEN100204010
• Company Name: Stockert GmbH
• Labeler DUNS: 327536314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-01
• Public Version: 2
• Public Version Date: 2026-01-19
• Public Version Status: Update
• Public Device Record Key: 37041d24-29b8-486d-b2ae-595d664ceda7

Device Description

only commercialized as part of the kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPB	Cardiac Ablation Percutaneous Catheter	Unknown		3
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260166374063	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]