BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GB-3

    DI: 14897076720146 · Model: GD5208 · TENS PLUS INDUSTRIAL COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GB-3
    Primary DI
    14897076720146
    Version / Model
    GD5208
    Catalog Number
    GD5208
    Company Name
    TENS PLUS INDUSTRIAL COMPANY
    Labeler DUNS
    663211978
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-30
    Public Version
    1
    Public Version Date
    2021-04-07
    Public Version Status
    New
    Public Device Record Key
    6a46edf0-2559-4091-bf54-9e88d891f6b9

    Device Description

    Model GB-3 Device emits heat from the heater and treats the afflicted part of the body, hands, legs, knee, shoulder etc. by placing it near the surface of the bare skin (at a distance directly over the skin surface). It is effective when deep heating of body tissue is desired.

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    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
    35147 Musculoskeletal infrared phototherapy unit, non-wearable

    Identifiers

    Type ID
    Primary 14897076720146

    Customer Contacts

    Phone
    18007228775
    Email
    [email protected]