BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Amcop Bioactivator

    DI: EMICBS1DTM1 · Model: BS1-DTM · MICERIUM SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Amcop Bioactivator
    Primary DI
    EMICBS1DTM1
    Version / Model
    BS1-DTM
    Catalog Number
    BS1-DTM
    Company Name
    MICERIUM SPA
    Labeler DUNS
    436661136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-05
    Public Version
    1
    Public Version Date
    2024-08-13
    Public Version Status
    New
    Public Device Record Key
    38f1d711-a4ea-4893-87af-5b423a1ffb4f

    Device Description

    Amcop Bioactivator AMCOP BIOACTIVATOR Class I Mod. S DTM Size 1 - 45 mm

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KMY Positioner, Tooth, Preformed

    GMDN Terms

    Code Name
    35310 Orthodontic retainer

    Identifiers

    Type ID
    Primary EMICBS1DTM1