BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MacBite

    DI: D10512178BX4 · Model: 12178-4 · Surgimac LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

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    Basic Information

    Brand Name
    MacBite
    Primary DI
    D10512178BX4
    Version / Model
    12178-4
    Company Name
    Surgimac LLC
    Labeler DUNS
    060635048
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2025-05-07
    Public Version
    1
    Public Version Date
    2025-05-15
    Public Version Status
    New
    Public Device Record Key
    c9934b69-55fe-4a72-bfd6-dc19adfd6b79

    Device Description

    Mac Bite Registration Material - 50ml, 4/BX

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Unit of Use D105121784
    Primary D10512178BX4

    Premarket Submissions

    Submission Number Supplement Number
    K221668 000