BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    American Biosurgical

    DI: 00849593025003 · Model: AB 1000-0 (S) · Advantage Medical Electronics, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    American Biosurgical
    Primary DI
    00849593025003
    Version / Model
    AB 1000-0 (S)
    Catalog Number
    CB-AB 1000-0 (S)
    Company Name
    Advantage Medical Electronics, LLC
    Labeler DUNS
    080242300
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-21
    Public Version
    3
    Public Version Date
    2023-02-10
    Public Version Status
    Update
    Public Device Record Key
    5fcab949-7866-4455-8af8-5a09f6f72b5e
    Distribution End Date
    2022-10-06

    Device Description

    Disposable, 12 Foot, Bipolar, Blue Cable, Blue Connectors, Sterile, Box 10

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    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
    Primary 00849593025003

    Premarket Submissions

    Submission Number Supplement Number
    K953889 000