Primary Device ID | 10628055481161 |
NIH Device Record Key | cfbc9ee1-8e91-4d59-8452-f878ddb77f63 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sterile transrectal needle guide with sheath |
Version Model Number | Single Unit |
Catalog Number | EV-29L-TRK-1 |
Company DUNS | 203044268 |
Company Name | Exact Imaging Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00628055481157 [Primary] |
GS1 | 10628055481161 [Package] Contains: 00628055481157 Package: [5 Units] In Commercial Distribution |
GS1 | 20628055481175 [Package] Contains: 00628055481157 Package: [24 Units] In Commercial Distribution |
OIJ | Biopsy Needle Guide Kit |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-11 |
Device Publish Date | 2021-02-03 |
00628055481140 - Non-Sterile Reusable Needle Guide - 16GA | 2022-05-23 Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer |
00628055481096 - EV5C Abdominal Transducer | 2021-02-11 EV5C is an abdominal end-fire transducer. |
10628055481116 - Sterile transperineal needle guide with sheath | 2021-02-11 Sterile transperineal needle guide with sheath for use with the EV29L transducer. |
10628055481161 - Sterile transrectal needle guide with sheath | 2021-02-11Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer |
10628055481161 - Sterile transrectal needle guide with sheath | 2021-02-11 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 Transducer | 2019-10-07 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 System | 2018-07-06 The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultras |
00628055481027 - ExactVu High Resolution Micro-Ultrasound System | 2018-07-06 The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultras |