BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Polylase

    DI: 90860002307018 · Model: AL · DDC TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Polylase
    Primary DI
    90860002307018
    Version / Model
    AL
    Catalog Number
    Polylase AL
    Company Name
    DDC TECHNOLOGIES, INC.
    Labeler DUNS
    128532707
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-09
    Public Version
    2
    Public Version Date
    2020-02-06
    Public Version Status
    Update
    Public Device Record Key
    03a07971-c2fa-47f5-8b4c-d9c34820ceb7

    Device Description

    Pulsed Alexandrite Laser

    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
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    47883 Dermatological solid-state laser system

    Identifiers

    Type ID
    Primary 90860002307018

    Customer Contacts

    Phone
    516-5941533
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K010715 000