BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WeRay

    DI: 08809840720046 · Model: P70A · PICOPACK Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WeRay
    Primary DI
    08809840720046
    Version / Model
    P70A
    Company Name
    PICOPACK Inc.
    Labeler DUNS
    694616916
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-24
    Public Version
    1
    Public Version Date
    2024-11-01
    Public Version Status
    New
    Public Device Record Key
    b5e30314-4d30-4615-bc11-c61295666f3e

    Device Description

    WERAY is a battery-operated, portable dental X-ray source designed for handheld operation. It is intended to produce diagnostic-quality X-ray images. The WERAY is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow the WERAY to be used. Still, transportation or using other X-ray devices might be prohibitive due to the other devices’ size and/or lack of mobility. The WERAY is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), a Cone for the sensor, Acryl shielding, a cradle, a Hand switch for X-ray exposure, and an AC/DC adaptor. The power is supplied by a rechargeable Lithium-ion polymer battery pack built into a main body. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. The acryl shielding provides sufficient radiation protection to allow the clinician to remain in the operatory with the patient. A hand switch is available to expose X-rays in a location away from the device. WERAY uses a fixed tube voltage of 70kV and a fixed tube current of 2.0 mA to make the system as simple as possible for the operator. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, a display panel, and an exposure button provide the primary operator interface. Exposure settings can be selected and displayed. The tube voltage (70 kV) and tube current (2.0 mA) are fixed, with the exposure time varying based on patient type, detector type, and anatomical features. Exposures can be completed using the exposure button. The WERAY should be used with an X-ray detector and a digital intraoral sensor. But the X-ray detector is not included in the device package.

    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
    EHD Unit, X-Ray, Extraoral With Timer

    GMDN Terms

    Code Name
    44606 Hand-held intraoral dental x-ray system, digital

    Identifiers

    Type ID
    Package 18809840720043
    Primary 08809840720046
    Package 28809840720040
    Package 38809840720047
    Package 48809840720044

    Customer Contacts

    Phone
    +82423625056
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K241963 000

    Device Sizes

    Type Value Unit Text
    Depth 106 Millimeter
    Height 269 Millimeter
    Width 302 Millimeter

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    80 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    5 – 85 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    15 – 40 Degrees Celsius
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    80 – 106 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    5 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius