BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PullUp Surgical Probe Cover

    DI: 00841912106424 · Model: 2005 · PROTEK MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PullUp Surgical Probe Cover
    Primary DI
    00841912106424
    Version / Model
    2005
    Catalog Number
    2005
    Company Name
    PROTEK MEDICAL PRODUCTS, INC.
    Labeler DUNS
    965417181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-13
    Public Version
    2
    Public Version Date
    2021-05-17
    Public Version Status
    Update
    Public Device Record Key
    c23296a2-b6d8-46da-9cdc-1722bfe9026d

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    44714 Intraoperative ultrasound imaging transducer cover

    Identifiers

    Type ID
    Package 10841912106421
    Primary 00841912106424

    Premarket Submissions

    Submission Number Supplement Number
    K970889 000
    K970893 000