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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Laserneedle Touch

    DI: 04260649160046 · Model: 12000-Trolley · Laserneedle GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Laserneedle Touch
    Primary DI
    04260649160046
    Version / Model
    12000-Trolley
    Company Name
    Laserneedle GmbH
    Labeler DUNS
    332288104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-14
    Public Version
    3
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    48ede6ee-1ce7-4c43-a94f-d81903a47b01

    Device Description

    Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213) - Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305) - LN Tape (Product number: 40100 Primary DI number: 4260649160466) - Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404) - LN Tip caps (Product number: 40710 Primary DI number: 4260649160503) - Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312) - Silicone applicators (Product number: 40410; Primary DI number: 4260649160411)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    60409 Musculoskeletal/physical therapy laser, professional

    Identifiers

    Type ID
    Primary 04260649160046