BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Max

    DI: D661M211 · Model: M21 · COLTENE/WHALEDENT INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    24

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    Basic Information

    Brand Name
    Max
    Primary DI
    D661M211
    Version / Model
    M21
    Company Name
    COLTENE/WHALEDENT INC
    Labeler DUNS
    622185718
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    24
    Record Status
    Published
    Publish Date
    2019-02-26
    Public Version
    2
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    d10e267a-d050-47bd-9b3c-6abad6e525d7

    Device Description

    MAX 021 Complete Kit

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EBL Pin, Retentive And Splinting, And Accessory Instruments

    GMDN Terms

    Code Name
    35868 Dental restoration retention pin

    Identifiers

    Type ID
    Primary D661M211
    Unit of Use D661M210