BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Integral® Omniloc™

    DI: 00889024011342 · Model: 0812 · ZIMMER DENTAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Integral® Omniloc™
    Primary DI
    00889024011342
    Version / Model
    0812
    Company Name
    ZIMMER DENTAL INC.
    Labeler DUNS
    103167086
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-24
    Public Version
    6
    Public Version Date
    2023-06-14
    Public Version Status
    Update
    Public Device Record Key
    897fcdfe-1d27-48bb-879a-36886137f195

    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
    No
    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", "Dry Heat Sterilization"]

    Product Codes

    Code Name
    DZE IMPLANT, ENDOSSEOUS, ROOT-FORM

    GMDN Terms

    Code Name
    44880 Dental implant suprastructure, temporary, preformed, single-use

    Identifiers

    Type ID
    Primary 00889024011342

    Customer Contacts

    Phone
    +1(800)854-7019
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 4.6mm