BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Delara

    DI: J014660715470 · Model: 66071547 · Kulzer GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Delara
    Primary DI
    J014660715470
    Version / Model
    66071547
    Catalog Number
    66071547
    Company Name
    Kulzer GmbH
    Labeler DUNS
    315666321
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-06
    Public Version
    2
    Public Version Date
    2024-10-30
    Public Version Status
    Update
    Public Device Record Key
    33e8d404-2355-43cf-a1b3-77b7d752abae

    Device Description

    Delara 8,A1/30L, CE

    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
    ELM Denture, plastic, teeth

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary J014660715470