Cardiodrive System 001-004115-12

GUDID M588001004115120

Robotic surgical navigation system

Primary Device ID	M588001004115120
NIH Device Record Key	16ddfd02-3522-497f-8faf-825216dbaa04
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cardiodrive System
Version Model Number	II
Catalog Number	001-004115-12
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	false
Lot Batch	false
Serial Number	true
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 Issuing Agency	Device ID
HIBCC	M588001004115120 [Primary]

DQX	Wire, Guide, Catheter

Steralize Prior To Use	false
Device Is Sterile	false

M588001004115120	The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatib
M588001004115110	The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatib
M58800100411590	The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatib