BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HandX Disposables

    DI: 07290017376035 · Model: 20-30-008-01 · HUMAN XTENSIONS LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HandX Disposables
    Primary DI
    07290017376035
    Version / Model
    20-30-008-01
    Catalog Number
    20-30-009-01
    Company Name
    HUMAN XTENSIONS LTD
    Labeler DUNS
    600165869
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-06
    Public Version
    2
    Public Version Date
    2022-01-26
    Public Version Status
    Update
    Public Device Record Key
    d356d5a7-06d6-45c9-91d0-0989268c7d8a

    Device Description

    HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    GCJ Laparoscope, General & Plastic Surgery
    NAY System, Surgical, Computer Controlled Instrument

    GMDN Terms

    Code Name
    58137 Endoscopic electromechanical surgical system

    Identifiers

    Type ID
    Package 17290017376032
    Primary 07290017376035