BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Aura XP

    DI: 00878953001685 · Model: 0010-8118H · AMERICAN MEDICAL SYSTEMS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aura XP
    Primary DI
    00878953001685
    Version / Model
    0010-8118H
    Company Name
    AMERICAN MEDICAL SYSTEMS
    Labeler DUNS
    796308653
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2019-02-13
    Public Version Status
    Update
    Public Device Record Key
    75fbe0de-d55c-4cde-baf0-6089c574c395
    Distribution End Date
    2019-01-23

    Device Description

    Laser System

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    36150 General/multiple surgical frequency-doubled solid-state laser system

    Identifiers

    Type ID
    Primary 00878953001685