BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ETHICON OMNEX

    DI: 10705031133105 · Model: 4901 · ETHICON INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ETHICON OMNEX
    Primary DI
    10705031133105
    Version / Model
    4901
    Catalog Number
    4901
    Company Name
    ETHICON INC.
    Labeler DUNS
    002144145
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-20
    Public Version
    3
    Public Version Date
    2019-07-19
    Public Version Status
    Update
    Public Device Record Key
    80eca7be-7529-4a2f-b81d-eb83d8fbd949
    Distribution End Date
    2019-07-18

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBE Sealant,polymerizing

    GMDN Terms

    Code Name
    34164 Skin-approximation adhesive

    Identifiers

    Type ID
    Package 30705031133109
    Primary 10705031133105
    Package 20705031133102

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Do Not Resterilize
    Type
    Storage Environment Temperature
    Temperature Range
    High: 25 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    High: 77 Degrees Fahrenheit