BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Single-Site

    DI: 00886874113752 · Model: 478115 · INTUITIVE SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Single-Site
    Primary DI
    00886874113752
    Version / Model
    478115
    Company Name
    INTUITIVE SURGICAL, INC.
    Labeler DUNS
    938647021
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-13
    Public Version
    16
    Public Version Date
    2023-08-30
    Public Version Status
    Update
    Public Device Record Key
    09607d33-3616-42d6-a05b-9308a74d7593

    Device Description

    WRISTED NEEDLE DRIVER

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GCJ Laparoscope, general & plastic surgery
    NAY System,surgical,computer controlled instrument

    GMDN Terms

    Code Name
    64421 Robotic surgical needle holder, reusable

    Identifiers

    Type ID
    Primary 00886874113752

    Device Sizes

    Type Value Unit Text
    Outer Diameter 5 Millimeter