Home GUDID 10628055481161 Sterile transrectal needle guide with sheath
Primary DI 10628055481161
Brand Sterile transrectal needle guide with sheath
Company Exact Imaging Inc
Model Single Unit
Catalog number EV-29L-TRK-1
Device description Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer
Published 2021-02-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OIJ Biopsy Needle Guide Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OIJ Biopsy Needle Guide Kit Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10628055481161 Package GS1 5 In Commercial Distribution 20628055481175 Package GS1 24 In Commercial Distribution 00628055481157 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 10628055481161 10628055481161 20628055481175 20628055481175 00628055481157 00628055481157 628055481157 0628055481157
GMDN Terms# Term, Definition table Term Definition Nonimplantable needle guide, single-use A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
Regulatory Flags# DUNS number 203044268 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 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 00628055481041 EV9C Transrectal Transducer EV9C EV-9C 2017-02-08
Other Devices Sharing Product Codes#