AccessGUDID - DEVICE: TSP Crosser Transseptal Access System (07290017811017)

GUDID

Device Identifier (DI) Information

Brand Name: TSP Crosser Transseptal Access System
Version or Model: TSUS001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRANSSEPTAL SOLUTIONS LTD

Primary DI Number: 07290017811017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532245789 *Terms of Use

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

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:	No
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
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
Special Storage Condition, Specify: Store in a cool, dark and dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03fdc336-461d-432c-b1b2-b6e6edd6471c
Public Version Date: May 09, 2019
Public Version Number: 4
DI Record Publish Date: April 19, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
57290017811012	5	07290017811017	In Commercial Distribution	Shipment box 5 pack
47290017811015	4	07290017811017	In Commercial Distribution	Shipment box 4 pack
37290017811018	3	07290017811017	In Commercial Distribution	Shipment box 3 pack
27290017811011	2	07290017811017	In Commercial Distribution	Shipment box 2 Pack
17290017811014	1	07290017811017	In Commercial Distribution	Shipment box 1 Pack