BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Invotec Quick Pack Nasal Balloon Packing

    DI: 00818501020683 · Model: 20-10715 · INVOTEC INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Invotec Quick Pack Nasal Balloon Packing
    Primary DI
    00818501020683
    Version / Model
    20-10715
    Catalog Number
    20-10715
    Company Name
    INVOTEC INTERNATIONAL, INC.
    Labeler DUNS
    622812592
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-06
    Public Version
    1
    Public Version Date
    2022-12-14
    Public Version Status
    New
    Public Device Record Key
    72973f83-8489-480b-8308-34e8b768a12f

    Device Description

    Invotec Quick Pack Nasal Balloon Packing, Silicone

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EMX Balloon, Epistaxis

    GMDN Terms

    Code Name
    12699 Nasal haemostatic balloon

    Identifiers

    Type ID
    Package 10818501020680
    Primary 00818501020683