BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Resident Expert Kinetic Testing Motion Detector

    DI: 00873263008119 · Model: C0259-00811 · FHC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resident Expert Kinetic Testing Motion Detector
    Primary DI
    00873263008119
    Version / Model
    C0259-00811
    Catalog Number
    C0259
    Company Name
    FHC, INC.
    Labeler DUNS
    108179458
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-20
    Public Version
    1
    Public Version Date
    2020-06-29
    Public Version Status
    New
    Public Device Record Key
    0c924d42-3d12-4f05-bdef-465ad7366e11

    Device Description

    Resident Expert Kinetic Testing Motion Detector, 1x

    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
    Yes
    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
    GZL ELECTRODE, DEPTH

    GMDN Terms

    Code Name
    11614 Evoked-potential graphic recording system

    Identifiers

    Type ID
    Primary 00873263008119

    Customer Contacts

    Phone
    +1(800)326-2905
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K183123 000