Needle Guide for use with the Exact Imaging EV29L Transducer EV-BIOG-1

GUDID 20628055481076

The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.

Exact Imaging Inc

Nonimplantable needle guide, single-use

• Primary Device ID: 20628055481076
• NIH Device Record Key: 503840cf-7bbd-4099-8ec1-21b8d1a8866a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle Guide for use with the Exact Imaging EV29L Transducer
• Version Model Number: Single Unit
• Catalog Number: EV-BIOG-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 Identifiers

Device Issuing Agency	Device ID
GS1	00628055481058 [Primary]
GS1	10628055481062 [Package]; Contains: 00628055481058; Package: [5 Units]; In Commercial Distribution
GS1	20628055481076 [Package]; Contains: 00628055481058; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162972

FDA Product Code

• OIJ: Biopsy Needle Guide Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-02-08

Devices Manufactured by Exact Imaging Inc

• 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: 2021-02-11 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: 2019-10-07The EV29L Sterile Biopsy 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