BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sutter Medical Technologies USA, Inc.

    DI: 00850006695041 · Model: SUT-491NS HR · SUTTER MEDICAL TECHNOLOGIES USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sutter Medical Technologies USA, Inc.
    Primary DI
    00850006695041
    Version / Model
    SUT-491NS HR
    Company Name
    SUTTER MEDICAL TECHNOLOGIES USA, INC.
    Labeler DUNS
    080438702
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-07
    Public Version
    2
    Public Version Date
    2020-04-21
    Public Version Status
    Update
    Public Device Record Key
    9c074d81-ff45-4eec-8f61-c52a0bd1a4b6

    Device Description

    Reusable Bipolar Forceps Insulated, K-Yasargil, Bayonet 7.12"(18.1cm), 0.5mm Tip, Non-Stick, Hidden Irrigation

    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
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    47848 Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

    Identifiers

    Type ID
    Primary 00850006695041

    Customer Contacts

    Phone
    7707027087
    Email
    [email protected]