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    FDA UDI In Commercial Distribution 🇺🇸 United States

    4-Way Lateral Expander Speculum - Large

    DI: M803038096 · Model: 4-Way Lateral Expander Speculum - Large 7/8" x 5 1/4" (22mm x 133mm) · MEDGYN PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    4-Way Lateral Expander Speculum - Large
    Primary DI
    M803038096
    Version / Model
    4-Way Lateral Expander Speculum - Large 7/8" x 5 1/4" (22mm x 133mm)
    Catalog Number
    038096
    Company Name
    MEDGYN PRODUCTS, INC.
    Labeler DUNS
    103913430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-26
    Public Version
    1
    Public Version Date
    2025-06-03
    Public Version Status
    New
    Public Device Record Key
    3a725e42-29a0-4940-838a-7bdd87ace6f0

    Device Description

    4-Way Lateral Expander Speculum - Large 7/8" x 5 1/4" (22mm x 133mm)

    Device Characteristics

    Single Use
    No
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    HDF Speculum, Vaginal, Metal

    GMDN Terms

    Code Name
    35352 Vaginal speculum, reusable

    Identifiers

    Type ID
    Primary M803038096