BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PEAKOSIL

    DI: 08800026400004 · Model: NS017C · NEOSIL Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PEAKOSIL
    Primary DI
    08800026400004
    Version / Model
    NS017C
    Company Name
    NEOSIL Co., Ltd
    Labeler DUNS
    690409169
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-20
    Public Version
    8
    Public Version Date
    2021-06-30
    Public Version Status
    Update
    Public Device Record Key
    ed2ad775-b273-4bf5-85f3-ecb62758fc07

    Device Description

    Product Name: PEAKOSIL Heavy Body Regular Set

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Primary 08800026400004
    Package 18800026400001
    Package 08800026400325

    Premarket Submissions

    Submission Number Supplement Number
    K152180 000