BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Etchmaster

    DI: 00817494020021 · Model: EM-S-K-RB · GROMAN INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    13
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Etchmaster
    Primary DI
    00817494020021
    Version / Model
    EM-S-K-RB
    Catalog Number
    EM-S-K-RB
    Company Name
    GROMAN INC.
    Labeler DUNS
    020124663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    4175a801-735d-499a-9274-740dad454a93
    Distribution End Date
    2026-08-29

    Device Description

    EtchMaster® disposable Small microetching tip pre-filled with 50 micron Aluminum Oxide (Color code marking BLACK) with Regular bend nozzle,

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    KOJ Airbrush

    GMDN Terms

    Code Name
    45403 Dental abrasive air jet system

    Identifiers

    Type ID
    Primary 00817494020021
    Package 10817494020028
    Package 20817494020025
    Package 30817494020022
    Package 40817494020029
    Package 50817494020026
    Package 60817494020023
    Package 70817494020020
    Package 80817494020027
    Package 90817494020024
    Package 11817494020027
    Package 12817494020027
    Package 13817494020027

    Customer Contacts

    Phone
    800-906-9298
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K030292 000