Home GUDID 00628055481041 EV9C Transrectal Transducer
Primary DI 00628055481041
Brand EV9C Transrectal Transducer
Company Exact Imaging Inc
Model EV9C
Catalog number EV-9C
Device description EV9C is a transrectal end-fire transducer.
Published 2017-02-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00628055481041 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 00628055481041 00628055481041 628055481041 0628055481041
GMDN Terms# Term, Definition table Term Definition Rectal/vaginal ultrasound imaging transducer An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.
Regulatory Flags# DUNS number 203044268 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00628055481225 EV29L Non-Sterile Reusable PrecisionPoint Adapter EV-BIOGR-PP EV-BIOGR-PP 2025-05-05 00628055481058 Needle Guide for use with the Exact Imaging EV29L Transducer Single Unit EV-BIOG-1 2017-02-08 00628055481102 Sterile transperineal needle guide with sheath Single Unit EV-29L-TPK-1 2021-02-03 00628055481157 Sterile transrectal needle guide with sheath Single Unit EV-29L-TRK-1 2021-02-03 00628055481140 Non-Sterile Reusable Needle Guide - 16GA EV-BIOG-R16 EV-BIOG-R16 2022-05-13 00628055481089 Reusable Needle Guide for use with the Exact Imaging EV29L Transducer Single Unit EV-BIOGR 2018-06-01 00628055481096 EV5C Abdominal Transducer EV5C EV-5C 2021-02-03 10628055481116 Sterile transperineal needle guide with sheath Single Unit EV-29L-TPK-1 2021-02-03 10628055481161 Sterile transrectal needle guide with sheath Single Unit EV-29L-TRK-1 2021-02-03 20628055481076 Needle Guide for use with the Exact Imaging EV29L Transducer Single Unit EV-BIOG-1 2017-02-08 00628055481010 ExactVu High Resolution Micro-Ultrasound System 1.0 EV-SYS-220 2017-02-08 00628055481027 ExactVu High Resolution Micro-Ultrasound System 1.0 EV-SYS-120 2017-02-08 00628055481034 EV29L Transrectal Transducer EV29L EV-29L 2017-02-08
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