BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    White Bite

    DI: 00850056330770 · Model: PB08 · White Bite, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

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    Basic Information

    Brand Name
    White Bite
    Primary DI
    00850056330770
    Version / Model
    PB08
    Catalog Number
    PB08
    Company Name
    White Bite, Inc.
    Labeler DUNS
    174136221
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2025-10-24
    Public Version
    1
    Public Version Date
    2025-11-03
    Public Version Status
    New
    Public Device Record Key
    dcb21f42-3119-46f5-8352-7247072fbadd

    Device Description

    Pediatric Preformed Matrix Band 08

    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
    JEP Retainer, Matrix

    GMDN Terms

    Code Name
    16195 Dental matrix band, reusable

    Identifiers

    Type ID
    Primary 00850056330770
    Unit of Use 10850056330777