NRG RF Transseptal Kit

GUDID 00685447004257

1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode

Baylis Médicale Cie Inc

Cardiac transseptal access set
Primary Device ID00685447004257
NIH Device Record Key58e94a61-4358-40e0-b9c4-c2a7e210cfaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameNRG RF Transseptal Kit
Version Model NumberNTK-711-8555N
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
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS100685447004257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2019-07-11
Device Publish Date2019-07-03

On-Brand Devices [NRG RF Transseptal Kit]

006854470029321 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470029251 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470029181 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470029011 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028951 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028881 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028711 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028641 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028571 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028401 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028331 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028261 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
006854470028191 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470028021 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027961 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027891 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027721 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027651 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027581 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027411 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027341 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027271 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027101 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470027031 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026971 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026801 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026731 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026661 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026591 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026421 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026351 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026281 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026111 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470026041 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470025981 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470025811 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015911 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015841 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015771 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015601 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015531 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015461 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015391 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015221 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015151 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470015081 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470014921 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470014851 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470014781 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
006854470014611 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1

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