Home GUDID 00852392007057 Guider Catheter Introducer
Primary DI 00852392007057
Brand Guider Catheter Introducer
Company RHYTHM XIENCE, INC.
Model 112852
Device description Guider - 65cm - L2 Guider Catheter Introducer 65 L2 8.5F
Published 2018-10-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00852392007057 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00852392007057 00852392007057 852392007057 0852392007057
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.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 035028367 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00852392007002 Flextra Steerable Introducer 122851 2018-10-29 00852392007019 Flextra Steerable Introducer 122852 2018-10-29 00852392007026 Guider Catheter Introducer 111851 2018-10-29 00852392007033 Guider Catheter Introducer 112851 2018-10-29 00852392007040 Guider Catheter Introducer 111852 2018-10-29
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