BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIEGO ELITE

    DI: 00821925042353 · Model: BEMTS101DC · Gyrus Acmi, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIEGO ELITE
    Primary DI
    00821925042353
    Version / Model
    BEMTS101DC
    Company Name
    Gyrus Acmi, Inc.
    Labeler DUNS
    007198742
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-05
    Public Version
    4
    Public Version Date
    2023-10-04
    Public Version Status
    Update
    Public Device Record Key
    0d0ef55a-cd9d-46b6-ab1f-85c4daf3a503

    Device Description

    BRACKET EM COMPATIBLE DIEGO ELITE

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

    GMDN Terms

    Code Name
    41589 ENT shaver system

    Identifiers

    Type ID
    Package 00821925042346
    Primary 00821925042353

    Premarket Submissions

    Submission Number Supplement Number
    K123429 000