BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ENDODRAPE®

    DI: B27810689076068659 · Model: 1 · VORTEK SURGICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENDODRAPE®
    Primary DI
    B27810689076068659
    Version / Model
    1
    Catalog Number
    68659
    Company Name
    VORTEK SURGICAL, LLC
    Labeler DUNS
    784805546
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-14
    Public Version
    1
    Public Version Date
    2019-10-22
    Public Version Status
    New
    Public Device Record Key
    ec31768d-1883-45ee-ab09-ab6fbe575f48

    Device Description

    ENDODRAPE® Colonoscopy, 49" x 52"

    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
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    47782 Patient surgical drape, single-use, non-sterile

    Identifiers

    Type ID
    Package B27820689076068659
    Primary B27810689076068659

    Customer Contacts

    Phone
    3173483555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K070406 000