AccessGUDID - DEVICE: NRG RF Transseptal Kit (00685447009948)

GUDID

Device Identifier (DI) Information

Brand Name: NRG RF Transseptal Kit
Version or Model: NTK-710-8555S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Baylis Médicale Cie Inc

Primary DI Number: 00685447009948
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 249225954 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47247	Cardiac transseptal access set	A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXF	Catheter, Septostomy
DQY	Catheter, Percutaneous
DRE	Dilator, Vessel, For Percutaneous Catheterization
DYB	Introducer, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 71cm Standard Curve C0 NRG Transseptal Needle; 8.5F 63cm TorFlex Transseptal Guiding Sheath with 55° curve; 175cm ProTrack Pigtail Wire

Device Record Status

Public Device Record Key: 938cd3e6-20d5-4410-a440-a9aeaeaa1095
Public Version Date: December 08, 2023
Public Version Number: 4
DI Record Publish Date: January 04, 2022