BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BLAZER INTRODUCER,BEVEL TIP

    DI: 00815212023637 · Model: ACC3140 · Izi Medical Products, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BLAZER INTRODUCER,BEVEL TIP
    Primary DI
    00815212023637
    Version / Model
    ACC3140
    Company Name
    Izi Medical Products, LLC
    Labeler DUNS
    933506164
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-14
    Public Version
    1
    Public Version Date
    2021-05-24
    Public Version Status
    New
    Public Device Record Key
    71ca00e0-afbd-4d37-8e12-2ba56d3a6d92

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    OCJ Spinal Channeling Instrument, Vertebroplasty

    GMDN Terms

    Code Name
    38563 Brain biopsy procedure kit

    Identifiers

    Type ID
    Primary 00815212023637

    Premarket Submissions

    Submission Number Supplement Number
    K070293 000