BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Reusable Needle Guide for use with the Exact Imaging EV29L Transducer

    DI: 00628055481089 · Model: Single Unit · Exact Imaging Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Reusable Needle Guide for use with the Exact Imaging EV29L Transducer
    Primary DI
    00628055481089
    Version / Model
    Single Unit
    Catalog Number
    EV-BIOGR
    Company Name
    Exact Imaging Inc
    Labeler DUNS
    203044268
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-01
    Public Version
    5
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    0fb14a12-76bf-4f55-b606-f02a0e3ef486

    Device Description

    The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the 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 00628055481089

    Premarket Submissions

    Submission Number Supplement Number
    K180636 000