BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QUICK Ray HD No Logo #2

    DI: 00858475006054 · Model: S11685-12 Hama Size #2 · DENTERPRISE INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QUICK Ray HD No Logo #2
    Primary DI
    00858475006054
    Version / Model
    S11685-12 Hama Size #2
    Company Name
    DENTERPRISE INTERNATIONAL, INC.
    Labeler DUNS
    024913248
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-01
    Public Version
    4
    Public Version Date
    2022-01-31
    Public Version Status
    Update
    Public Device Record Key
    7fa7d596-c8da-47e0-8419-6f758406f3d0

    Device Description

    Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    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

    GMDN Terms

    Code Name
    44905 Dental digital imaging sensor, intraoral

    Identifiers

    Type ID
    Primary 00858475006054

    Customer Contacts

    Phone
    8003232690
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 70 Degrees Celsius