BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Director Sterile Disposable Needle Gudie

    DI: 00841912101030 · Model: 4020 · PROTEK MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Director Sterile Disposable Needle Gudie
    Primary DI
    00841912101030
    Version / Model
    4020
    Catalog Number
    4020
    Company Name
    PROTEK MEDICAL PRODUCTS, INC.
    Labeler DUNS
    965417181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    9
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    a52b2dde-4214-46e0-b4bd-7a1bae50b8cd

    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
    Yes
    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
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    45018 Needle guide, single-use

    Identifiers

    Type ID
    Package 10841912101037
    Primary 00841912101030

    Premarket Submissions

    Submission Number Supplement Number
    K973958 000