BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sklar®

    DI: 10649111112409 · Model: 10-1113S · SKLAR CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Sklar®
    Primary DI
    10649111112409
    Version / Model
    10-1113S
    Company Name
    SKLAR CORPORATION
    Labeler DUNS
    006966006
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    c4b83ccc-11a3-4203-928d-1733e3f2213a

    Device Description

    SAMPLE INDICATOR STRIPS STEAM

    Device Characteristics

    Single Use
    Yes
    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
    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
    No

    Product Codes

    Code Name
    JOJ Indicator, physical/chemical sterilization process

    GMDN Terms

    Code Name
    37284 Enzymatic sterilization indicator

    Identifiers

    Type ID
    Primary 10649111112409

    Premarket Submissions

    Submission Number Supplement Number
    K890759 000