BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Clarus Digital Control Module

    DI: 10810004821016 · Model: 5190-500 · CLARUS MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Clarus Digital Control Module
    Primary DI
    10810004821016
    Version / Model
    5190-500
    Catalog Number
    5190-500
    Company Name
    CLARUS MEDICAL, LLC
    Labeler DUNS
    010316284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-19
    Public Version
    1
    Public Version Date
    2024-02-27
    Public Version Status
    New
    Public Device Record Key
    360c4eb5-404c-48a9-a9f4-56a369648f5d

    Device Description

    Clarus Digital Control Module

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWG Endoscope, Neurological

    GMDN Terms

    Code Name
    34540 Endoscopic video image processing/light source system

    Identifiers

    Type ID
    Direct Marking 00810004821019
    Primary 10810004821016

    Customer Contacts

    Phone
    763-525-8400
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K223615 000