BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Quala

    DI: D02318201QU1 · Model: 18201-QU · NATIONAL DISTRIBUTION & CONTRACTING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Quala
    Primary DI
    D02318201QU1
    Version / Model
    18201-QU
    Catalog Number
    18201-QU
    Company Name
    NATIONAL DISTRIBUTION & CONTRACTING, INC.
    Labeler DUNS
    009831413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-11
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    bf6e325d-df9a-446b-9d51-b50f154d8797

    Device Description

    Quala Intraoral X-ray Film QD57 Adult D Speed DBL

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IWZ Film, Radiographic

    GMDN Terms

    Code Name
    40978 Dental x-ray film, non-screen

    Identifiers

    Type ID
    Primary D02318201QU1
    Package D02318201QU31

    Customer Contacts

    Phone
    6153663230
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 21 Degrees Celsius