BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sterile Disposable Endocavity Needle Guide

    DI: 00841912106301 · Model: 5390 · PROTEK MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sterile Disposable Endocavity Needle Guide
    Primary DI
    00841912106301
    Version / Model
    5390
    Catalog Number
    5390
    Company Name
    PROTEK MEDICAL PRODUCTS, INC.
    Labeler DUNS
    965417181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-13
    Public Version
    5
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    86322b74-2b1c-4bc2-9f0a-8a7f4c0b0581

    Device Description

    Sterile Disposable Endocavity Needle Guide for use with Philips -ATL C9-5, C9-5ec & C9-5ICT Ultrasound Transducers

    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
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    45018 Needle guide, single-use

    Identifiers

    Type ID
    Package 10841912106308
    Primary 00841912106301

    Premarket Submissions

    Submission Number Supplement Number
    K971115 000
    K971722 000