BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    White Bite

    DI: 00850056330008 · Model: E5 · White Bite, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    White Bite
    Primary DI
    00850056330008
    Version / Model
    E5
    Catalog Number
    E5
    Company Name
    White Bite, Inc.
    Labeler DUNS
    174136221
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2025-10-27
    Public Version
    1
    Public Version Date
    2025-11-04
    Public Version Status
    New
    Public Device Record Key
    7df180d3-2a42-467d-b99a-a0ef1cde9052

    Device Description

    Pediatric Strip Crown Form E5

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KCQ Tube Impression And Matrix

    GMDN Terms

    Code Name
    42344 Dental mould

    Identifiers

    Type ID
    Primary 00850056330008
    Unit of Use 10850056330005