BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACU-GUARD

    DI: 10814105020859 · Model: ADG51 · ACUDERM, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACU-GUARD
    Primary DI
    10814105020859
    Version / Model
    ADG51
    Company Name
    ACUDERM, INC.
    Labeler DUNS
    071426803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-03
    Public Version
    1
    Public Version Date
    2020-01-13
    Public Version Status
    New
    Public Device Record Key
    8caa6921-6fd2-4595-87fa-c2ca010e8a13

    Device Description

    Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    63712 Medical equipment drape, single-use, non-sterile

    Identifiers

    Type ID
    Primary 10814105020859

    Customer Contacts

    Phone
    954-733-6935
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K915000 000