BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SCHICK ELITE

    DI: D764B22501501 · Model: B2250150 · SIRONA DENTAL, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SCHICK ELITE
    Primary DI
    D764B22501501
    Version / Model
    B2250150
    Company Name
    SIRONA DENTAL, INC.
    Labeler DUNS
    078613913
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    4
    Public Version Date
    2022-12-09
    Public Version Status
    Update
    Public Device Record Key
    dea1ef34-06f4-49d9-9400-6dde874d545a

    Device Description

    USB REMOTE HS / ELITE CABLE (5 METER)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MUH System,X-Ray,Extraoral Source,Digital
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
    EHD Unit, X-Ray, Extraoral With Timer

    GMDN Terms

    Code Name
    60743 Medical device USB cable

    Identifiers

    Type ID
    Primary D764B22501501

    Customer Contacts

    Phone
    (877) 724-4254
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K072134 000