BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ever GUIDE KIT

    DI: 08806343924032 · Model: RW00 · Shinhung MST Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ever GUIDE KIT
    Primary DI
    08806343924032
    Version / Model
    RW00
    Company Name
    Shinhung MST Co., Ltd.
    Labeler DUNS
    689667152
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-16
    Public Version
    1
    Public Version Date
    2025-06-24
    Public Version Status
    New
    Public Device Record Key
    0065f881-8b83-45d2-8b5f-b0fd67fc45d4

    Device Description

    This is a dental implant surgical instrument used when separating a broken prosthesis and screw from the fixture.

    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
    EJB Handle, Instrument, Dental

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 08806343924032

    Customer Contacts

    Phone
    +82337301913
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    1 – 30 Degrees Celsius