BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cardiovascular Procedure Kit

    DI: 00699753531468 · Model: 78091-01 · Terumo Cardiovascular Systems Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Cardiovascular Procedure Kit
    Primary DI
    00699753531468
    Version / Model
    78091-01
    Company Name
    Terumo Cardiovascular Systems Corporation
    Labeler DUNS
    177655466
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-28
    Public Version
    3
    Public Version Date
    2026-03-02
    Public Version Status
    Update
    Public Device Record Key
    b5601aed-5289-4f1c-8c1a-e8cb00af7179
    Distribution End Date
    2026-03-01

    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
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    38821 Endoscopic-access dilator, single-use

    Identifiers

    Type ID
    Primary 00699753531468