BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PS Tip

    DI: 08800016273250 · Model: PS Tip · Hironic Co., ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PS Tip
    Primary DI
    08800016273250
    Version / Model
    PS Tip
    Company Name
    Hironic Co., ltd.
    Labeler DUNS
    557803630
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-15
    Public Version
    1
    Public Version Date
    2026-04-23
    Public Version Status
    New
    Public Device Record Key
    9756ec87-55d0-4a48-b2cc-a68407c5606d

    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
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    44776 Electrosurgical system

    Identifiers

    Type ID
    Primary 08800016273250

    Customer Contacts

    Phone
    +8215992499
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K233123 000
    K251334 000