BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSure® Disposable Vaginal Speculum

    DI: 10704411002260 · Model: 1 · AMSINO INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

    Basic Information

    Brand Name
    AMSure® Disposable Vaginal Speculum
    Primary DI
    10704411002260
    Version / Model
    1
    Catalog Number
    AS032M
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    dc97dc92-54c4-4f53-8b3e-2c28faae36e7

    Device Description

    AMSure® Disposable Vaginal Speculum Graves Style, Clean, Ready For Use

    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
    Yes
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIB Speculum, Vaginal, Nonmetal

    GMDN Terms

    Code Name
    37468 Vaginal speculum, single-use

    Identifiers

    Type ID
    Package 40704411002261
    Primary 10704411002260
    Unit of Use 00704411002263