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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN

    DI: 00843356101690 · Model: IT0612-SI · CYGNUS MEDICAL L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN
    Primary DI
    00843356101690
    Version / Model
    IT0612-SI
    Company Name
    CYGNUS MEDICAL L.L.C.
    Labeler DUNS
    103169095
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    1
    Public Version Date
    2020-10-02
    Public Version Status
    New
    Public Device Record Key
    5eeeae2b-e9e9-4d85-859b-3b0b8b7d276d

    Device Description

    Bundle - IT0612, SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED INSTRUMENTS" tamper-proof label with adhesive backing - 100 Trays & 100 Labels

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PXV General Purpose Instrument Tray

    GMDN Terms

    Code Name
    61665 Surgical instrument containment holder, single-use, non-sterile

    Identifiers

    Type ID
    Unit of Use 30843356101691
    Primary 00843356101690