Home GUDID B3000399139500 EpiAccess Needle
Primary DI B3000399139500
Brand EpiAccess Needle
Company EPIEP, INC.
Model 0399-13950
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 B3000399139500 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Pericardiocentesis needle, single-use A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed for the puncture of the pericardial cavity for the aspiration (removal) of fluids (pericardiocentesis). The device is typically long and rigid enough to penetrate the pericardium (e.g., 10 to 18 centimetres in length). This is a single-use device.
Regulatory Flags# DUNS number 965279909 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B300A00020 EpiAccess Control Unit A0002 2016-09-23 B300A00050 EpiAccess Control Unit A0005 2017-09-18
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