BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    retainer

    DI: D818125300 · Model: Argen retainer Premium · ARGEN CORPORATION, THE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    retainer
    Primary DI
    D818125300
    Version / Model
    Argen retainer Premium
    Catalog Number
    125300
    Company Name
    ARGEN CORPORATION, THE
    Labeler DUNS
    103095543
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-19
    Public Version
    2
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    9d19942e-4f73-44cd-9cdf-25dcd6b75db1

    Device Description

    orthodontic retainer

    Device Characteristics

    Single Use
    Yes
    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
    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
    NXC Aligner, Sequential

    GMDN Terms

    Code Name
    35310 Orthodontic retainer

    Identifiers

    Type ID
    Primary D818125300

    Premarket Submissions

    Submission Number Supplement Number
    K183229 000