BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    N.A.

    DI: J011611120000 · Model: 611-120-00 · DENTAURUM GmbH & Co.KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    N.A.
    Primary DI
    J011611120000
    Version / Model
    611-120-00
    Company Name
    DENTAURUM GmbH & Co.KG
    Labeler DUNS
    315427286
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    4a1dbcfc-172c-458e-9837-7ceca18b8173
    Distribution End Date
    2017-06-01

    Device Description

    Safety key for palex®/Variety screws

    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
    33592 Orthodontic teeth positioner, preformed

    Identifiers

    Type ID
    Primary J011611120000
    Unit of Use J011611120001

    Customer Contacts

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

    Storage Conditions

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