BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dynamic Lead Wire Set

    DI: 00853818007286 · Model: PB-40 · PRECISION BIOMETRICS INC
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dynamic Lead Wire Set
    Primary DI
    00853818007286
    Version / Model
    PB-40
    Company Name
    PRECISION BIOMETRICS INC
    Labeler DUNS
    362997926
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-13
    Public Version
    4
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    89c9b0a5-7c85-43f5-99ad-8c8b565ba217

    Device Description

    40" Dynamic Lead Wire Set (WireFree)

    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
    KQX Goniometer, Ac-Powered
    HCS Device, Temperature Measurement, Direct Contact, Powered
    HCC Device, Biofeedback
    IKN Electromyograph, Diagnostic

    GMDN Terms

    Code Name
    35750 Analytical non-scalp cutaneous lead

    Identifiers

    Type ID
    Primary 00853818007286

    Premarket Submissions

    Submission Number Supplement Number
    K123399 000