BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Perfit FS

    DI: 08800099911513 · Model: FH C14 B1M · Vatech mcis Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    Perfit FS
    Primary DI
    08800099911513
    Version / Model
    FH C14 B1M
    Company Name
    Vatech mcis Co., Ltd
    Labeler DUNS
    688284886
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2023-12-08
    Public Version
    1
    Public Version Date
    2023-12-18
    Public Version Status
    New
    Public Device Record Key
    96c749ff-c5a9-49a4-a8ee-adb823220be1

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Unit of Use 08800099966582
    Primary 08800099911513

    Premarket Submissions

    Submission Number Supplement Number
    K203590 000
    K222686 000