BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    American Biosurgical

    DI: 00849593019873 · Model: CB-AB 5004 · Advantage Medical Electronics, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    American Biosurgical
    Primary DI
    00849593019873
    Version / Model
    CB-AB 5004
    Company Name
    Advantage Medical Electronics, LLC
    Labeler DUNS
    080242300
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-01
    Public Version
    2
    Public Version Date
    2023-02-10
    Public Version Status
    Update
    Public Device Record Key
    b153f1f3-adb4-4b22-892f-437d3fd51a11

    Device Description

    Reusable, 10 foot, Monopolar, Grey Cable, Bovie Plug to 90 Degree Female Socket, Non-Sterile

    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
    Yes
    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
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 00849593019873
    Package 10849593019870
    Package 00849593019880

    Premarket Submissions

    Submission Number Supplement Number
    K971540 000