BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MyoSure Rod Lens Hysteroscope

    DI: 15420045510203 · Model: 40-200 · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MyoSure Rod Lens Hysteroscope
    Primary DI
    15420045510203
    Version / Model
    40-200
    Company Name
    Hologic, Inc.
    Labeler DUNS
    018925968
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-03
    Public Version
    3
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    82b9b195-f7af-4ef7-a4a5-be04db84f290

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    HIH HYSTEROSCOPE (AND ACCESSORIES)

    GMDN Terms

    Code Name
    36628 Rigid optical hysteroscope

    Identifiers

    Type ID
    Primary 15420045510203

    Premarket Submissions

    Submission Number Supplement Number
    K091465 000