BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cottle Speculum, 110mm flared tip

    DI: 00810009465331 · Model: 99-200-09 · MIZUHO AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cottle Speculum, 110mm flared tip
    Primary DI
    00810009465331
    Version / Model
    99-200-09
    Company Name
    MIZUHO AMERICA, INC.
    Labeler DUNS
    877624940
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-23
    Public Version
    1
    Public Version Date
    2023-01-31
    Public Version Status
    New
    Public Device Record Key
    1472d087-1c72-491d-9f05-09d5824201bb

    Device Description

    Speculum

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    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
    EPY Speculum, Ent

    GMDN Terms

    Code Name
    35350 Nasal speculum, reusable

    Identifiers

    Type ID
    Primary 00810009465331