BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX

    DI: 00850470007630 · Model: 19G · RESTORATION ROBOTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX
    Primary DI
    00850470007630
    Version / Model
    19G
    Catalog Number
    FP-102778
    Company Name
    RESTORATION ROBOTICS, INC.
    Labeler DUNS
    627212587
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-12
    Public Version
    1
    Public Version Date
    2018-12-13
    Public Version Status
    New
    Public Device Record Key
    e610ac96-11c2-4b18-a641-0487dd4e583a

    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
    ONA Computer Assisted Hair Harvesting System

    GMDN Terms

    Code Name
    35290 Hair extraction punch

    Identifiers

    Type ID
    Primary 00850470007630

    Premarket Submissions

    Submission Number Supplement Number
    K173358 000