BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Guided Surgery Accessories Kit - UniFit Implants

    DI: 07290116770307 · Model: GSK005 · ADIN DENTAL IMPLANT SYSTEMS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Guided Surgery Accessories Kit - UniFit Implants
    Primary DI
    07290116770307
    Version / Model
    GSK005
    Company Name
    ADIN DENTAL IMPLANT SYSTEMS LTD
    Labeler DUNS
    533289435
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-07
    Public Version
    1
    Public Version Date
    2024-01-15
    Public Version Status
    New
    Public Device Record Key
    c10b647e-e313-44b7-83cb-4d9053f13085

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    OFY Dental Implant Surgical Tray

    GMDN Terms

    Code Name
    45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 07290116770307