Home GUDID 15415067042313 NA
Primary DI 15415067042313
Brand NA
Company ST. JUDE MEDICAL, INC.
Model LT100
Catalog number LT100
Device description Mechanical Heart Valve Leaflet Tester
Published 2023-05-19
Public version status New
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 LXN PROBE, TEST, HEART-VALVE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXN Probe, Test, Heart-Valve Cardiovascular 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15415067042313 Package GS1 20 In Commercial Distribution 05415067004772 Previous GS1 0 05415067042316 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 15415067042313 15415067042313 05415067004772 05415067004772 5415067004772 05415067042316 05415067042316 5415067042316
GMDN Terms# Term, Definition table Term Definition Heart valve prosthesis tester, single-use A sterile, pen-like device intended to be used to manually manipulate a heart valve prosthesis to perform an assessment of the valvular prosthesis (e.g., its ability to open and close) prior to implantation and/or when in situ. It typically has a handle made of plastic and a soft tip (e.g., made of rubber) to prevent damage of the valvular prosthesis. This is a single-use device.
Regulatory Flags# DUNS number 149818952 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false 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# Other Devices Sharing Product Codes# 
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