INTELLAGEN™ Remote Control M004GEN100204030

GUDID 04260166374100

Only commercialized as part of the kit

Stockert GmbH

Cardiac radio-frequency ablation system generator

• Primary Device ID: 04260166374100
• NIH Device Record Key: 768d3fa8-cfb0-4275-9eeb-accaf3f79f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTELLAGEN™ Remote Control
• Version Model Number: 20406
• Catalog Number: M004GEN100204030
• Company DUNS: 327536314
• Company Name: Stockert GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260166374100 [Primary]

FDA Product Code

• OAD: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-09
• Device Publish Date: 2024-09-01

Devices Manufactured by Stockert GmbH

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• 04260166373080 - INTELLAGEN™ Grounding Cable (3m): 2024-09-09
• 04260166373097 - INTELLAGEN™ ECG Connection Cable (3m): 2024-09-09
• 04260166373103 - INTELLAGEN™ Serial Communication Cable (5m): 2024-09-09
• 04260166373110 - INTELLAGEN™ Serial Communication Cable (15m): 2024-09-09
• 04260166373127 - INTELLAGEN™ Remote Control Connection Cable (25m): 2024-09-09
• 04260166373134 - INTELLAGEN™ Irrigation Pump Connection Cable (5m): 2024-09-09
• 04260166373158 - INTELLAGEN™ Catheter Adapter Cable (0.3m): 2024-09-09