BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VERSAJET III Hydrosurgery System Console

    DI: 05000223498092 · Model: 66802146 · SMITH & NEPHEW MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VERSAJET III Hydrosurgery System Console
    Primary DI
    05000223498092
    Version / Model
    66802146
    Catalog Number
    66802146
    Company Name
    SMITH & NEPHEW MEDICAL LIMITED
    Labeler DUNS
    216344051
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-31
    Public Version
    2
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    b3d7178f-9318-4dc1-b3ee-90253d5251b7

    Device Description

    VERSAJET III HYDROSURGERY SYSTEM CONSOLE

    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
    FQH Lavage, Jet

    GMDN Terms

    Code Name
    36961 Water jet knife system generator

    Identifiers

    Type ID
    Primary 05000223498092

    Premarket Submissions

    Submission Number Supplement Number
    K220964 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 498x600x282

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 55 Degrees Celsius