NRG RF Transseptal Kit

GUDID 00685447004028

1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 x Dispersive Electrode

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

Primary Device ID	00685447004028
NIH Device Record Key	510fdb1c-c54d-4668-bbf7-b6818d4d66a6
Commercial Distribution Status	In Commercial Distribution
Brand Name	NRG RF Transseptal Kit
Version Model Number	NTK-711-8590
Company DUNS	249225954
Company Name	Baylis Médicale Cie 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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com
Phone	5144889801
Email	info@baylismedical.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447004028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K073326

FDA Product Code

DXF	Catheter, Septostomy

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-07-11
Device Publish Date	2019-07-03

On-Brand Devices [NRG RF Transseptal Kit]

00685447002932	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002925	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002918	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002901	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002895	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002888	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002871	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002864	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002857	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002840	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002833	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002826	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x Dispersive Electrode
00685447002819	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002802	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002796	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002789	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002772	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002765	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002758	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002741	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002734	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002727	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002710	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002703	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002697	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002680	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002673	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002666	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002659	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002642	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002635	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002628	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002611	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002604	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002598	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447002581	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001591	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001584	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001577	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001560	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001553	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001546	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001539	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001522	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001515	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001508	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001492	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001485	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001478	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1
00685447001461	1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1