Sterile transperineal needle guide with sheath EV-29L-TPK-1

GUDID 10628055481116

Sterile transperineal needle guide with sheath for use with the EV29L transducer.

Exact Imaging Inc

Nonimplantable needle guide, single-use
Primary Device ID10628055481116
NIH Device Record Key36389be4-ef19-447a-8390-fd01a393279e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile transperineal needle guide with sheath
Version Model NumberSingle Unit
Catalog NumberEV-29L-TPK-1
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628055481102 [Primary]
GS110628055481116 [Package]
Contains: 00628055481102
Package: [5 Units]
In Commercial Distribution
GS120628055481120 [Package]
Contains: 00628055481102
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

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 sheath2021-02-11Sterile transperineal needle guide with sheath for use with the EV29L 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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