VersaCross Large Access Solution

GUDID 00685447017561

1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))

Baylis Médicale Cie Inc

Cardiac transseptal access set
Primary Device ID00685447017561
NIH Device Record Key4b3ddca9-a64b-4e70-848a-8efcc9523b16
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaCross Large Access Solution
Version Model NumberVLAK0013
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 Kittrue
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
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
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
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100685447017561 [Primary]

FDA Product Code

DXFCatheter, Septostomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-04
Device Publish Date2022-07-27

On-Brand Devices [VersaCross Large Access Solution]

006854470069161 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470069091 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068791 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068621 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068311 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068241 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470067941 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470067871 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470069301 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470069231 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068931 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068861 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068551 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068481 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068171 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470068001 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470125591 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470125421 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470125351 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470125281 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470125111 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470125041 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124981 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124811 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124741 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124671 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124501 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124431 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124361 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124291 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124121 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470124051 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175921 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175851 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175781 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175611 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175541 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175471 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175301 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175231 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175161 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470175091 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470174931 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470174861 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470174791 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470174621 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470174551 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x
006854470174481 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x

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