BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Zibone

    DI: 04710986430079 · Model: Zr-I4011 · COHO BIOMEDICAL TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Zibone
    Primary DI
    04710986430079
    Version / Model
    Zr-I4011
    Company Name
    COHO BIOMEDICAL TECHNOLOGY CO., LTD.
    Labeler DUNS
    658658526
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-03
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    4cd37dfd-1788-4530-ba2d-6948c2768097

    Device Description

    One piece zirconia dental implant. Diameter : 4 mm, Length : 11.5 mm

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form
    NHA Abutment, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    55847 Dental implant system

    Identifiers

    Type ID
    Primary 04710986430079