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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sterile transperineal needle guide with sheath

    DI: 00628055481102 · Model: Single Unit · Exact Imaging Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sterile transperineal needle guide with sheath
    Primary DI
    00628055481102
    Version / Model
    Single Unit
    Catalog Number
    EV-29L-TPK-1
    Company Name
    Exact Imaging Inc
    Labeler DUNS
    203044268
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-03
    Public Version
    4
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    36389be4-ef19-447a-8390-fd01a393279e

    Device Description

    Sterile transperineal needle guide with sheath for use with the EV29L transducer.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OIJ Biopsy Needle Guide Kit

    GMDN Terms

    Code Name
    45018 Needle guide, single-use

    Identifiers

    Type ID
    Package 10628055481116
    Primary 00628055481102
    Package 20628055481120

    Premarket Submissions

    Submission Number Supplement Number
    K192303 000