BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Polyaxial Screw 8.5 x 70mm

    DI: M739151128570 · Model: 15112-8570 · CAPTIVA SPINE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Polyaxial Screw 8.5 x 70mm
    Primary DI
    M739151128570
    Version / Model
    15112-8570
    Company Name
    CAPTIVA SPINE, INC.
    Labeler DUNS
    836975784
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-08
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    6f080533-261d-4b79-85d2-18b2152fc0dc
    Distribution End Date
    2017-08-14

    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    MNI Orthosis, Spinal Pedicle Fixation
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    GMDN Terms

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

    Identifiers

    Type ID
    Primary M739151128570