BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Needle Guide

    DI: 10841912106629 · Model: 5480 · PROTEK MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    250

    Basic Information

    Brand Name
    Disposable Needle Guide
    Primary DI
    10841912106629
    Version / Model
    5480
    Company Name
    PROTEK MEDICAL PRODUCTS, INC.
    Labeler DUNS
    965417181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    250
    Record Status
    Published
    Publish Date
    2020-06-01
    Public Version
    5
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    883f880b-8ef1-485f-9c79-4892e942f29f

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    45018 Needle guide, single-use

    Identifiers

    Type ID
    Unit of Use 00841912106622
    Primary 10841912106629

    Premarket Submissions

    Submission Number Supplement Number
    K971115 000
    K971722 000