BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bipolar Cord

    DI: B089B681150 · Model: B68115 · BLACK & BLACK SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bipolar Cord
    Primary DI
    B089B681150
    Version / Model
    B68115
    Catalog Number
    B68115
    Company Name
    BLACK & BLACK SURGICAL, INC.
    Labeler DUNS
    004382282
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    feba97c4-4d7a-45af-86bc-957811fca0a7

    Device Description

    BIPOLAR CORD; VALLEY LAB, LAMIDEY, EMC, 2 PIN-PLUG

    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    61876 Open-surgery electrosurgical electrode, monopolar, reusable

    Identifiers

    Type ID
    Primary B089B681150

    Customer Contacts

    Phone
    877-252-2517
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K072124 000