BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptraGate 2

    DI: 07615208513660 · Model: 762098WW · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    OptraGate 2
    Primary DI
    07615208513660
    Version / Model
    762098WW
    Catalog Number
    762098WW
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2024-11-19
    Public Version
    2
    Public Version Date
    2024-12-03
    Public Version Status
    Update
    Public Device Record Key
    c9ada54b-521f-4363-b6cc-2960874bf500

    Device Description

    OptraGate 2 Test Pack 2x1

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIF ACCESSORIES, RETRACTOR, DENTAL

    GMDN Terms

    Code Name
    63315 Dental cheek retractor, professional, single-use

    Identifiers

    Type ID
    Unit of Use 07615208526455
    Primary 07615208513660