BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PASS OCT

    DI: 03613720197805 · Model: B17190075 · MEDICREA INTERNATIONAL
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PASS OCT
    Primary DI
    03613720197805
    Version / Model
    B17190075
    Company Name
    MEDICREA INTERNATIONAL
    Labeler DUNS
    383228632
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-23
    Public Version
    6
    Public Version Date
    2023-03-28
    Public Version Status
    Update
    Public Device Record Key
    b045bdab-c33f-4d6d-8fab-79a2947c56c7
    Distribution End Date
    2023-03-24

    Device Description

    LAMINAR HOOK, 7.5MM GROOVE

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

    Product Codes

    Code Name
    NKG Orthosis, Cervical Pedicle Screw Spinal Fixation
    KWP Appliance, Fixation, Spinal Interlaminal

    GMDN Terms

    Code Name
    61325 Bone-screw internal spinal fixation system, non-sterile

    Identifiers

    Type ID
    Primary 03613720197805