BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    N.A.

    DI: J011607149000 · Model: 607-149-00 · DENTAURUM GmbH & Co.KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    N.A.
    Primary DI
    J011607149000
    Version / Model
    607-149-00
    Company Name
    DENTAURUM GmbH & Co.KG
    Labeler DUNS
    315427286
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    6
    Public Version Date
    2022-10-21
    Public Version Status
    Update
    Public Device Record Key
    03ef1331-bd3c-40c8-a294-28d914823d49
    Distribution End Date
    2020-06-19

    Device Description

    SUS² telescope rod

    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
    No

    Product Codes

    Code Name
    DYJ RETAINER, SCREW EXPANSION, ORTHODONTIC

    GMDN Terms

    Code Name
    65677 Orthodontic palate expander screw, bonded

    Identifiers

    Type ID
    Primary J011607149000
    Unit of Use J011607149001

    Customer Contacts

    Phone
    +1(800)523-3946
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    No special storage conditions required