BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ASSI

    DI: 00841645100997 · Model: 153104BP · 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
    00841645100997
    Version / Model
    153104BP
    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
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    ce607fd1-add0-4850-b4f7-eeb6916162fb

    Device Description

    Jewelers Foot Controlled Titanium BP Fcps 10.5cm,Str. Tip 0.4mm Dia.

    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
    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 00841645100997

    Premarket Submissions

    Submission Number Supplement Number
    K811820 000