EV9C Transrectal Transducer EV-9C

GUDID 00628055481041

EV9C is a transrectal end-fire transducer.

Exact Imaging Inc

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00628055481041
NIH Device Record Keyb7c8acff-28c0-4ca8-9ba4-0b7cf7d1a8d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEV9C Transrectal Transducer
Version Model NumberEV9C
Catalog NumberEV-9C
Company DUNS203044268
Company NameExact Imaging Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628055481041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-07-06
Device Publish Date2017-02-08

Devices Manufactured by Exact Imaging Inc

00628055481140 - Non-Sterile Reusable Needle Guide - 16GA2022-05-23 Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer
00628055481096 - EV5C Abdominal Transducer2021-02-11 EV5C is an abdominal end-fire transducer.
10628055481116 - Sterile transperineal needle guide with sheath2021-02-11 Sterile transperineal needle guide with sheath for use with the EV29L transducer.
10628055481161 - Sterile transrectal needle guide with sheath2021-02-11 Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer
00628055481089 - Reusable Needle Guide for use with the Exact Imaging EV29L Transducer 2019-12-23 The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
20628055481076 - Needle Guide for use with the Exact Imaging EV29L Transducer2019-10-07 The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
00628055481010 - ExactVu High Resolution Micro-Ultrasound System2018-07-06 The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultras
00628055481027 - ExactVu High Resolution Micro-Ultrasound System2018-07-06 The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultras

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