VersaCross Connect LAAC Access Solution NA

GUDID 00685447012610

1 x VersaCross Connect 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 Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set
Primary Device ID00685447012610
NIH Device Record Keyb83d555c-9619-4a55-81c7-19e0134697bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaCross Connect LAAC Access Solution
Version Model NumberVXAK0011
Catalog NumberNA
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
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Phone5144889801
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Phone5144889801
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Phone5144889801
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Phone5144889801
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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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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
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
GS100685447012610 [Primary]

FDA Product Code

DREDilator, Vessel, For Percutaneous Catheterization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-22
Device Publish Date2022-08-12

On-Brand Devices [VersaCross Connect LAAC Access Solution]

006854470105791 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470105621 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470105551 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470105481 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470105241 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470105171 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470105001 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470104941 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470184071 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470183911 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470183841 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470183771 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470183601 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470183531 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470183461 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470183391 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470126341 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470126271 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470126101 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470126031 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470125971 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470125801 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470125731 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
006854470125661 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x Versa
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