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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Percutaneous Micro-Introducer Kit

    DI: 00886333214990 · Model: 497801 · ARGON MEDICAL DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Percutaneous Micro-Introducer Kit
    Primary DI
    00886333214990
    Version / Model
    497801
    Catalog Number
    497801
    Company Name
    ARGON MEDICAL DEVICES, INC.
    Labeler DUNS
    140727624
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    0a37c8b4-f8e0-4bd0-bb8b-ce4807c34755

    Device Description

    4F Percutaneous Micro-Introducer Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OFL Percutaneous Sheath Introducer Kit

    GMDN Terms

    Code Name
    46488 Magnetocardiography system

    Identifiers

    Type ID
    Package 10886333214997
    Primary 00886333214990
    Package 20886333214994

    Customer Contacts

    Phone
    1.800.927.4669
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 4F