Reusable Needle Guide for use with the Exact Imaging EV29L Transducer EV-BIOGR

GUDID 00628055481089

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

Exact Imaging Inc

Nonimplantable needle guide, reusable

• Primary Device ID: 00628055481089
• NIH Device Record Key: 0fb14a12-76bf-4f55-b606-f02a0e3ef486
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Needle Guide for use with the Exact Imaging EV29L Transducer
• Version Model Number: Single Unit
• Catalog Number: EV-BIOGR
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00628055481089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180636

FDA Product Code

• OIJ: Biopsy Needle Guide Kit

Sterilization

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

[00628055481089]

Moist Heat or Steam Sterilization

[00628055481089]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-06-01

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: 2019-12-23The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the 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