BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SURGICAL INSTRUMENTATION

    DI: 07290110723910 · Model: DL-XR · HI-TEC IMPLANTS LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SURGICAL INSTRUMENTATION
    Primary DI
    07290110723910
    Version / Model
    DL-XR
    Catalog Number
    DL-XR
    Company Name
    HI-TEC IMPLANTS LTD.
    Labeler DUNS
    600710917
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-07
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    131589df-be46-4150-8d0a-0cd433df50a2

    Device Description

    BONE TAP

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Liquid Chemical", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    NHA Abutment, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    44883 Dental implant/prosthesis surgical procedure kit

    Identifiers

    Type ID
    Primary 07290110723910