BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NOVO Health Services, LLC

    DI: 00812564032980 · Model: 123581 · NOVO HEALTH SERVICES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NOVO Health Services, LLC
    Primary DI
    00812564032980
    Version / Model
    123581
    Catalog Number
    123581D
    Company Name
    NOVO HEALTH SERVICES, LLC
    Labeler DUNS
    069936106
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    4
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    3804a6be-901d-404d-99b6-3315cb75e169
    Distribution End Date
    2020-06-02

    Device Description

    PLR SET UP PACK

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FYA Gown, Surgical

    GMDN Terms

    Code Name
    11902 Surgical gown, reusable

    Identifiers

    Type ID
    Primary 00812564032980

    Customer Contacts

    Phone
    8138919550
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K031933 000
    K090383 000

    Device Sizes

    Type Value Unit Text
    Weight 8.1 Pound
    Width 13 Inch
    Height 9 Inch