BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ASSI

    DI: 00841645103554 · Model: AC2000 · ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ASSI
    Primary DI
    00841645103554
    Version / Model
    AC2000
    Company Name
    ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
    Labeler DUNS
    055870299
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-25
    Public Version
    4
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    f6f1918d-537f-4e88-a7aa-33d5b02bfd9e

    Device Description

    Polarmate II Electrosurgical Unit W/Footswitch

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    11490 Electrosurgical system generator

    Identifiers

    Type ID
    Primary 00841645103554

    Premarket Submissions

    Submission Number Supplement Number
    K944775 000