BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Distraction Screw, 14MM pouch

    DI: 00818614022581 · Model: SM-0089 · Maruho Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Distraction Screw, 14MM pouch
    Primary DI
    00818614022581
    Version / Model
    SM-0089
    Company Name
    Maruho Medical, Inc.
    Labeler DUNS
    117630237
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-01
    Public Version
    3
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    ccfa6fee-da16-454d-9188-4fb759c11ac2

    Device Description

    Surgix Distraction Screw, 14MM pouch

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    LYQ Accessories, Fixation, Spinal Intervertebral Body

    GMDN Terms

    Code Name
    62546 Intraoperative orthopaedic bone pin/screw, single-use

    Identifiers

    Type ID
    Package 10818614022588
    Primary 00818614022581