Non-Sterile Reusable Needle Guide - 16GA EV-BIOG-R16

GUDID 00628055481140

Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer

Exact Imaging Inc

Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable

• Primary Device ID: 00628055481140
• NIH Device Record Key: 6c6e1b82-2c30-4323-9a11-2e95a9389ae7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Sterile Reusable Needle Guide - 16GA
• Version Model Number: EV-BIOG-R16
• Catalog Number: EV-BIOG-R16
• 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	00628055481140 [Primary]

FDA Product Code

• OIJ: Biopsy Needle Guide Kit

Sterilization

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

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

[00628055481140]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-13

Devices Manufactured by Exact Imaging Inc

• 00628055481140 - Non-Sterile Reusable Needle Guide - 16GA: 2022-05-23Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer
• 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: 2019-10-07 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