TSP Crosser Transseptal Access System

Basic Information

• Brand Name: TSP Crosser Transseptal Access System
• Primary DI: 07290017811017
• Version / Model: TSUS001
• Company Name: TRANSSEPTAL SOLUTIONS LTD
• Labeler DUNS: 532245789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-19
• Public Version: 4
• Public Version Date: 2019-05-09
• Public Version Status: Update
• Public Device Record Key: 03fdc336-461d-432c-b1b2-b6e6edd6471c

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017811017	GS1
Package	57290017811012	GS1	Shipment box 5 pack	5	In Commercial Distribution
Package	47290017811015	GS1	Shipment box 4 pack	4	In Commercial Distribution
Package	37290017811018	GS1	Shipment box 3 pack	3	In Commercial Distribution
Package	27290017811011	GS1	Shipment box 2 Pack	2	In Commercial Distribution
Package	17290017811014	GS1	Shipment box 1 Pack	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dark and dry place