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    FDA UDI In Commercial Distribution 🇺🇸 United States

    exofin HVTA, 1g

    DI: 00854137001146 · Model: EX70410 · CHEMENCE MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    exofin HVTA, 1g
    Primary DI
    00854137001146
    Version / Model
    EX70410
    Catalog Number
    EX70410
    Company Name
    CHEMENCE MEDICAL PRODUCTS, INC.
    Labeler DUNS
    079163089
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2022-02-15
    Public Version Status
    Update
    Public Device Record Key
    29eee607-3a3e-4cf8-a52b-b1361d447bd5

    Device Description

    HVTA

    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
    MPN Tissue Adhesive For The Topical Approximation Of Skin

    GMDN Terms

    Code Name
    34164 Skin-approximation adhesive

    Identifiers

    Type ID
    Primary 00854137001146
    Package 00854137001221
    Package 10854137001228

    Customer Contacts

    Phone
    844-633-6583
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152476 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 86 Degrees Fahrenheit