BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    A. Titan Instruments

    DI: 00841685111113 · Model: SLK7 · A. TITAN INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    A. Titan Instruments
    Primary DI
    00841685111113
    Version / Model
    SLK7
    Company Name
    A. TITAN INSTRUMENTS, INC.
    Labeler DUNS
    037738874
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-13
    Public Version
    1
    Public Version Date
    2023-01-23
    Public Version Status
    New
    Public Device Record Key
    0a69f5a3-d828-40c9-825b-24d851b6f99d

    Device Description

    OTA7, SINUS LIFT INSTRUMENT

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    Yes
    Sterilization Methods
    Dry Heat Sterilization

    Product Codes

    Code Name
    DZN Instruments, Dental Hand

    GMDN Terms

    Code Name
    64314 Dental elevator, sinus lift

    Identifiers

    Type ID
    Primary 00841685111113