BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sklar

    DI: 10649111439322 · Model: 40-3211C · SKLAR CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sklar
    Primary DI
    10649111439322
    Version / Model
    40-3211C
    Company Name
    SKLAR CORPORATION
    Labeler DUNS
    006966006
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-19
    Public Version
    1
    Public Version Date
    2019-03-27
    Public Version Status
    New
    Public Device Record Key
    d9ca68ed-db8a-4847-8ae8-1cdca7e99fe0

    Device Description

    CENSITRAC READY SYNOVECTOMY RONG STRG CV 1.2MM

    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
    Yes
    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
    HTX RONGEUR

    GMDN Terms

    Code Name
    46752 Synovectomy rongeur

    Identifiers

    Type ID
    Primary 10649111439322