Home GUDID 07290017811000 TSP Crosser Transseptal Access System
Primary DI 07290017811000
Brand TSP Crosser Transseptal Access System
Company TRANSSEPTAL SOLUTIONS LTD
Model TSUS001
Device description The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers.
Published 2019-04-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290017811017 Package GS1 1 In Commercial Distribution 17290017811007 Package GS1 1 In Commercial Distribution 17290017811014 Package GS1 1 In Commercial Distribution 27290017811011 Package GS1 2 In Commercial Distribution 37290017811018 Package GS1 3 In Commercial Distribution 47290017811015 Package GS1 4 In Commercial Distribution 57290017811005 Package GS1 5 In Commercial Distribution 57290017811012 Package GS1 5 In Commercial Distribution 07290017811000 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290017811017 07290017811017 7290017811017 17290017811007 17290017811007 17290017811014 17290017811014 27290017811011 27290017811011 37290017811018 37290017811018 47290017811015 47290017811015 57290017811005 57290017811005 57290017811012 57290017811012 07290017811000 07290017811000 7290017811000
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dark and dry place
Regulatory Flags# DUNS number 532245789 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290017811017 TSP Crosser Transseptal Access System TSUS001 2019-04-19
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