BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    American Biosurgical

    DI: 00849593019835 · Model: CB-AB 6003-G-NS · Advantage Medical Electronics, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    American Biosurgical
    Primary DI
    00849593019835
    Version / Model
    CB-AB 6003-G-NS
    Company Name
    Advantage Medical Electronics, LLC
    Labeler DUNS
    080242300
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-02
    Public Version
    2
    Public Version Date
    2023-02-10
    Public Version Status
    Update
    Public Device Record Key
    b8052557-0f6b-4f52-835a-bd68db534939

    Device Description

    Disposable, 12 foot, Bipolar, Green Cable, Wolf to Banana, Non-Sterile

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    47143 Electrical-only medical device connection cable, single-use

    Identifiers

    Type ID
    Package 00849593019842
    Primary 00849593019835

    Premarket Submissions

    Submission Number Supplement Number
    K953889 000