SmartAblateTM System

GUDID 04260166371758

Stockert GmbH

Radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 04260166371758
• NIH Device Record Key: 66bfc960-6f00-4959-80e0-9d11b4ac8589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartAblateTM System
• Version Model Number: M490006
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260166371758 [Primary]

FDA Product Code

• LPB: Cardiac Ablation Percutaneous Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-23

Devices Manufactured by Stockert GmbH

• 04260166371314 - SmartAblate Gen-Rem Cable: 2018-05-28 SmartAblate Connection Cable Generator - Remote (30 m)
• 04260166371321 - SmartAblate Foot Pedal ext. Cable: 2018-05-28 SmartAblate Foot Pedal extension cable (7 m)
• 04260166371345 - SMARTABLATE-SCom. Recording-/CARTO® Cable: 2018-05-28 SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
• 04260166371352 - SMARTABLATE SCom. Recording-/CARTO® Cable: 2018-05-28 SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m
• 04260166370041 - GLOBAL PORT: 2018-05-10
• 04260166370195 - STOCKERT 70: 2018-05-10
• 04260166370256 - STOCKERT REMOTE CONTROL: 2018-05-10
• 04260166370300 - STOCKERT EP/IO Interface Box: 2018-05-10