BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Advantage™ Blue System

    DI: 08714729961918 · Model: M0068502050 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Advantage™ Blue System
    Primary DI
    08714729961918
    Version / Model
    M0068502050
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-22
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    6051e883-82bd-488f-ba7b-18fa3c60495c

    Device Description

    Transvaginal Mid-Urethral Sling

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OTN mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

    GMDN Terms

    Code Name
    47986 Female stress urinary incontinence surgical mesh-sling, synthetic polymer

    Identifiers

    Type ID
    Primary 08714729961918