BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    AMS 700

    DI: 00878953003054 · Model: 72404123 · AMERICAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMS 700
    Primary DI
    00878953003054
    Version / Model
    72404123
    Company Name
    AMERICAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    125111448
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-25
    Public Version
    6
    Public Version Date
    2019-02-13
    Public Version Status
    Update
    Public Device Record Key
    3e0a783c-0cf7-4662-a1ae-1d25223b551e
    Distribution End Date
    2019-01-23

    Device Description

    IPP Surgical Tool System 1 AMS Connector Tool 1 AMS Insertion Package 1 AMS Furlow Cylinder Inserter 1 Proximal Tool (Sterile)

    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
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    JCW Prosthesis, Penis, Inflatable

    GMDN Terms

    Code Name
    32864 Wire/ligature passer, reusable

    Identifiers

    Type ID
    Primary 00878953003054