BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GEN2

    DI: 00840343722074 · Model: G2OB1569 · SURGIX MEDICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GEN2
    Primary DI
    00840343722074
    Version / Model
    G2OB1569
    Catalog Number
    G2OB1569
    Company Name
    SURGIX MEDICAL LLC
    Labeler DUNS
    080402644
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-22
    Public Version
    1
    Public Version Date
    2024-05-30
    Public Version Status
    New
    Public Device Record Key
    dbf0cb5a-ab10-4236-9674-d75eea4b23c2

    Device Description

    Cohen Acorn Small Cone, Tube 3.24mm, TL 31.0mm OL 60mm(2 3/8")

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    63993 Uterine probe

    Identifiers

    Type ID
    Primary 00840343722074

    Customer Contacts

    Phone
    888-247-0477
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K060233 000

    Device Sizes

    Type Value Unit Text
    Length 2.325 Inch