BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DC-Air™ Intraoral Sensor

    DI: 06429810587213 · Model: WIOS-S2-BLACK · Athlos Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DC-Air™ Intraoral Sensor
    Primary DI
    06429810587213
    Version / Model
    WIOS-S2-BLACK
    Company Name
    Athlos Oy
    Labeler DUNS
    368444471
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-03
    Public Version
    1
    Public Version Date
    2022-11-11
    Public Version Status
    New
    Public Device Record Key
    faf5e834-1b06-4b5b-bb6d-370b63f634ce

    Device Description

    DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.

    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
    No
    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
    Package 06429810587220
    Primary 06429810587213