V-Loop Variable Loop Catheter Manipulator

Primary DI
M58800100245210
Brand
V-Loop Variable Loop Catheter Manipulator
Company
Stereotaxis, Inc.
Model
1
Catalog number
001-002452-1
Device description
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
Published
2016-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
DXXSystem, Catheter Control, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DXXSystem, Catheter Control, SteerableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M58800100245210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system workstationA mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13146786100info@stereotaxis.com

Regulatory Flags#

DUNS number
024942265
Device count
1
Lot or batch
true
Expiration date on label
true

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