EPstar Fixed Electrophysiology Catheter

GUDID 00685447003748

8 electrodes; Electrode spacing: 5-5-5 mm

Baylis Médicale Cie Inc

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Primary Device ID00685447003748
NIH Device Record Key005d2954-8a13-4f25-b5e2-785befad6f1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPstar Fixed Electrophysiology Catheter
Version Model NumberDCF-2-8-55-130
Company DUNS249225954
Company NameBaylis Médicale Cie Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com

Device Dimensions

Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French
Length130 Centimeter
Catheter Gauge2 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100685447003748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCatheter, Electrode Recording, Or Probe, Electrode Recording

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-09
Device Publish Date2019-08-30

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