BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ChannelScope, Long, 10K

    DI: 00810004820937 · Model: 2232-002 · CLARUS MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ChannelScope, Long, 10K
    Primary DI
    00810004820937
    Version / Model
    2232-002
    Catalog Number
    2232-002
    Company Name
    CLARUS MEDICAL, LLC
    Labeler DUNS
    010316284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-28
    Public Version
    2
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    9e7cafda-7f6c-41b0-8d71-42f96e5e2ec7

    Device Description

    ChannelScope, 10K Pixels, Long, 21.6cm Working Length

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWG Endoscope, Neurological

    GMDN Terms

    Code Name
    45045 Rigid optical intracranial/spinal endoscope, single-use

    Identifiers

    Type ID
    Primary 00810004820937

    Premarket Submissions

    Submission Number Supplement Number
    K945633 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius