BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACUWEDGE

    DI: D832WG161 · Model: WG-16 · PLASDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    ACUWEDGE
    Primary DI
    D832WG161
    Version / Model
    WG-16
    Catalog Number
    WG-16
    Company Name
    PLASDENT CORPORATION
    Labeler DUNS
    190377184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2021-12-14
    Public Version
    2
    Public Version Date
    2024-02-05
    Public Version Status
    Update
    Public Device Record Key
    3381acbd-907b-4ece-b8ad-19955ca6bd44

    Device Description

    Plastic Wedge, 16mm (L), Purple, Disposable

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    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
    NRD Unit, Operative Dental, Accessories

    GMDN Terms

    Code Name
    45007 Dental wedge, single-use

    Identifiers

    Type ID
    Unit of Use D832WG160
    Primary D832WG161