BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Symphion

    DI: 08714729897279 · Model: FG-0612-R · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Symphion
    Primary DI
    08714729897279
    Version / Model
    FG-0612-R
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2022-07-20
    Public Version Status
    Update
    Public Device Record Key
    3a390549-d13d-47fb-aa5b-529849a2cda3
    Distribution End Date
    2021-01-19

    Device Description

    Tissue Removal System Refurbished Controller

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PGT Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar

    GMDN Terms

    Code Name
    36122 Hysteroscopic irrigation/insufflation system

    Identifiers

    Type ID
    Primary 08714729897279