BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EndoSheath Technology

    DI: 00874485003005 · Model: TV-1.5 · COGENTIX MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EndoSheath Technology
    Primary DI
    00874485003005
    Version / Model
    TV-1.5
    Catalog Number
    03-5102
    Company Name
    COGENTIX MEDICAL, INC.
    Labeler DUNS
    780024725
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    e93008b6-119d-4624-acbc-52d8080f1654

    Device Description

    EndoSheath Technology for the TNE-5000 Video Esophagoscope

    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
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EOX Esophagoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    44711 Optical medical device procedural cover

    Identifiers

    Type ID
    Package 20874485003016
    Primary 00874485003005

    Customer Contacts

    Phone
    866-258-2182
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K072088 000