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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-Sterile Reusable Needle Guide - 16GA

    DI: 00628055481140 · Model: EV-BIOG-R16 · Exact Imaging Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Non-Sterile Reusable Needle Guide - 16GA
    Primary DI
    00628055481140
    Version / Model
    EV-BIOG-R16
    Catalog Number
    EV-BIOG-R16
    Company Name
    Exact Imaging Inc
    Labeler DUNS
    203044268
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-13
    Public Version
    2
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    6c6e1b82-2c30-4323-9a11-2e95a9389ae7

    Device Description

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

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    OIJ Biopsy Needle Guide Kit

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Primary 00628055481140