BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-Sterile Latex Endocavity Probe Cover

    DI: 10841912100924 · Model: 3235 · PROTEK MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    40

    Basic Information

    Brand Name
    Non-Sterile Latex Endocavity Probe Cover
    Primary DI
    10841912100924
    Version / Model
    3235
    Catalog Number
    3235
    Company Name
    PROTEK MEDICAL PRODUCTS, INC.
    Labeler DUNS
    965417181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    40
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    4
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    ef9bb96d-8d97-42ec-bd3d-1743ff0c5ec3

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    60609 Body-orifice ultrasound imaging transducer cover, basic, non-sterile

    Identifiers

    Type ID
    Primary 10841912100924
    Unit of Use 00841912100927

    Premarket Submissions

    Submission Number Supplement Number
    K970891 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight