BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MacBite

    DI: D105BR9003MB2 · Model: BR-9003-MB · Surgimac LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    MacBite
    Primary DI
    D105BR9003MB2
    Version / Model
    BR-9003-MB
    Company Name
    Surgimac LLC
    Labeler DUNS
    060635048
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2025-06-04
    Public Version
    1
    Public Version Date
    2025-06-12
    Public Version Status
    New
    Public Device Record Key
    0bfe2d59-a351-417d-80f1-fbccd9c4410c

    Device Description

    MacBite Registration Material, Unflavored Super Fast Set, 2 - 50 mL Cartridges and 6 Mixing Tips

    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
    17844 Dental articulation paste/solution

    Identifiers

    Type ID
    Unit of Use D105BR9003MB0
    Primary D105BR9003MB2