BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-Sterile Single-Use Endocavity Probe Cover

    DI: 40841912103315 · Model: 2201 · PROTEK MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Non-Sterile Single-Use Endocavity Probe Cover
    Primary DI
    40841912103315
    Version / Model
    2201
    Catalog Number
    1-219-2201EDM
    Company Name
    PROTEK MEDICAL PRODUCTS, INC.
    Labeler DUNS
    965417181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2021-07-07
    Public Version
    1
    Public Version Date
    2021-07-15
    Public Version Status
    New
    Public Device Record Key
    022ad2ba-fcb4-419c-a5af-822138d195c6

    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
    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
    Unit of Use 00841912103317
    Primary 40841912103315

    Premarket Submissions

    Submission Number Supplement Number
    K970893 000

    Storage Conditions

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