BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HI-I®

    DI: B715080010480 · Model: 08001-048 · FRICKE INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HI-I®
    Primary DI
    B715080010480
    Version / Model
    08001-048
    Catalog Number
    08001-048
    Company Name
    FRICKE INTERNATIONAL, INC.
    Labeler DUNS
    957630726
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-26
    Public Version
    2
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    4162261d-cd8f-40c4-92fa-d5c380fcc7e7

    Device Description

    #2 "D" Fib HI-I®

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBI Resin, Denture, Relining, Repairing, Rebasing

    GMDN Terms

    Code Name
    16730 Dental appliance fabrication material, resin

    Identifiers

    Type ID
    Primary B715080010480

    Customer Contacts

    Phone
    630-540-1900
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Weight 48 Gram