BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sklar®

    DI: 10649111344480 · Model: 31-2258 · SKLAR CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sklar®
    Primary DI
    10649111344480
    Version / Model
    31-2258
    Company Name
    SKLAR CORPORATION
    Labeler DUNS
    006966006
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-16
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    86f2e518-9a5a-4da3-877c-feefa2dc7454

    Device Description

    5000 SUCTION/IRRIGATION SYSTEM SINGLE VALVE

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    GCX APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

    GMDN Terms

    Code Name
    61870 Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

    Identifiers

    Type ID
    Primary 10649111344480