BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Reprocessed ECTRA II, Triangle Knife

    DI: B39044481 · Model: 4448 · SURETEK MEDICAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Reprocessed ECTRA II, Triangle Knife
    Primary DI
    B39044481
    Version / Model
    4448
    Company Name
    SURETEK MEDICAL
    Labeler DUNS
    785616934
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-13
    Public Version
    1
    Public Version Date
    2024-02-21
    Public Version Status
    New
    Public Device Record Key
    3e4fc122-445e-4ec2-85fe-cf52d3eeee7a

    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
    Yes
    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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    58783 Hand ligament surgical release instrument

    Identifiers

    Type ID
    Primary B39044481