BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SCOPE BUDDY PLUS TUBING

    DI: 00677964082986 · Model: SB-110-HU1012 · MEDIVATORS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SCOPE BUDDY PLUS TUBING
    Primary DI
    00677964082986
    Version / Model
    SB-110-HU1012
    Catalog Number
    SB110HU1012
    Company Name
    MEDIVATORS INC.
    Labeler DUNS
    068199363
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-04
    Public Version
    9
    Public Version Date
    2023-11-01
    Public Version Status
    Update
    Public Device Record Key
    2f642226-ef18-4a43-aacb-1feabc256010

    Device Description

    Scope Buddy Plus, 24 Hour Auxiliary Detergent Out Tube

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No

    Product Codes

    Code Name
    FEB Accessories, Cleaning, For Endoscope

    GMDN Terms

    Code Name
    60417 Luer/non-ISO80369-standardized linear connector, reusable

    Identifiers

    Type ID
    Primary 00677964082986
    Package 10677964082983
    Package 20677964082980

    Premarket Submissions

    Submission Number Supplement Number
    K162128 000
    K213833 000