V-Loop Variable Loop Catheter Manipulator 001-002452-1

GUDID M58800100245210

The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures

Stereotaxis, Inc.

Cardiac mapping system workstation

• Primary Device ID: M58800100245210
• NIH Device Record Key: 96307819-3c70-4167-9672-03f5491171c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Loop Variable Loop Catheter Manipulator
• Version Model Number: 1
• Catalog Number: 001-002452-1
• Company DUNS: 024942265
• Company Name: Stereotaxis, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M58800100245210 [Primary]

FDA Product Code

• DXX: System, Catheter Control, Steerable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-07-17
• Device Publish Date: 2016-05-02

Devices Manufactured by Stereotaxis, Inc.

• M58800100175110 - QuikCAS Cardiodrive Sterile Components: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M5880010017711 - QuikCAS Hemostasis Adapter: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M5880010017712 - Cardiodrive Hemostasis Adapter - SJ: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M58800100230710 - Vdrive System: 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
• M58800100230720 - Vdrive System: 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
• M58800100242210 - V-CAS Catheter Advancement System: 2024-07-17 The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible m
• M58800100245210 - V-Loop Variable Loop Catheter Manipulator: 2024-07-17The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures
• M58800100245210 - V-Loop Variable Loop Catheter Manipulator: 2024-07-17 The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loo
• M58800100246910 - V-Sono Intracardiac Echo Manipulator: 2024-07-17 Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection