BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CUSTOM

    DI: 03613720283294 · Model: A99191605 · MEDICREA INTERNATIONAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CUSTOM
    Primary DI
    03613720283294
    Version / Model
    A99191605
    Catalog Number
    A99191605
    Company Name
    MEDICREA INTERNATIONAL
    Labeler DUNS
    383228632
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-19
    Public Version
    4
    Public Version Date
    2023-03-15
    Public Version Status
    Update
    Public Device Record Key
    b5305b0e-c791-4359-9891-1cb5548e80e9
    Distribution End Date
    2023-01-10

    Device Description

    PASS TULIP 40mm TAP Ø10.5mm

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 03613720283294