BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monoart

    DI: E3072640050 · Model: KIT MONOART DENTIST CHAIR COVER · EURONDA SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monoart
    Primary DI
    E3072640050
    Version / Model
    KIT MONOART DENTIST CHAIR COVER
    Catalog Number
    264005
    Company Name
    EURONDA SPA
    Labeler DUNS
    428755441
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-17
    Public Version
    1
    Public Version Date
    2019-12-25
    Public Version Status
    New
    Public Device Record Key
    db541cdf-ad25-4a2e-aaf6-8c8431acd698

    Device Description

    A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: lilac

    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
    Yes
    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
    NRU Chair, Dental, Without Operative Unit

    GMDN Terms

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

    Identifiers

    Type ID
    Primary E3072640050
    Package E3072640052
    Package E3072640051