BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ML 830®

    DI: 00859626006107 · Model: ML-830-02-000 · MICROLIGHT CORPORATION OF AMERICA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ML 830®
    Primary DI
    00859626006107
    Version / Model
    ML-830-02-000
    Catalog Number
    ML-830-02-000
    Company Name
    MICROLIGHT CORPORATION OF AMERICA
    Labeler DUNS
    137829417
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-15
    Public Version
    5
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    3ceb26a1-e422-4672-9025-3890109a2dc9

    Device Description

    Original Direct Connect

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    NHN Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

    GMDN Terms

    Code Name
    60410 Musculoskeletal/physical therapy laser, home-use

    Identifiers

    Type ID
    Primary 00859626006107

    Customer Contacts

    Phone
    281-433-4648
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K010175 000