BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Reusable Endocavity Needle Guide

    DI: 10841912102669 · Model: 6456 · PROTEK MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Reusable Endocavity Needle Guide
    Primary DI
    10841912102669
    Version / Model
    6456
    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
    7
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    518e6cae-418f-42f4-8fca-26b2ceb4579e

    Device Description

    Stainless Steel Reusable Endocavity Needle Guide for Ultrasonix EC9-5/10, Prosonic EC10R and Samsung Medison EV4-9/10ED & ER4-9/10ED Ultrasound Transducers

    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
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Direct Marking 00841912102662
    Primary 10841912102669

    Premarket Submissions

    Submission Number Supplement Number
    K971115 000
    K971722 000