BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Dilators

    DI: 00878953005355 · Model: 720117-01 · AMERICAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Dilators
    Primary DI
    00878953005355
    Version / Model
    720117-01
    Company Name
    AMERICAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    125111448
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    4
    Public Version Date
    2019-02-13
    Public Version Status
    Update
    Public Device Record Key
    7ab58aaf-86fb-4d02-a73d-870c8f7bcfb1

    Device Description

    Disposable Dilators, Set of 4 Dilators (9-16 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator 1) 13-14 mm Dilator 1) 15-16 mm Dilator

    Device Characteristics

    Single Use
    Yes
    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
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KOA Surgical Instruments, G-U, Manual (And Accessories)

    GMDN Terms

    Code Name
    58389 Corpus cavernosum dilator, single-use

    Identifiers

    Type ID
    Primary 00878953005355

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 15 to 16 mm
    Device Size Text, specify 13 to 14 mm
    Device Size Text, specify 11 to 12 mm
    Device Size Text, specify 9 to 10 mm