BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    4CIS® Marlin ACIF Cage SYSTEM

    DI: 08806373583285 · Model: 5901-0145 · SOLCO BIOMEDICAL CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    4CIS® Marlin ACIF Cage SYSTEM
    Primary DI
    08806373583285
    Version / Model
    5901-0145
    Catalog Number
    5901-0145
    Company Name
    SOLCO BIOMEDICAL CO.,LTD.
    Labeler DUNS
    687844241
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-12
    Public Version
    3
    Public Version Date
    2020-03-05
    Public Version Status
    Update
    Public Device Record Key
    92c540ab-8f6d-48c9-b4ac-833274c528fa

    Device Description

    4CIS® Marlin Trial 14x12, H5

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    GMDN Terms

    Code Name
    60725 Transfemoral amputation tissue-reinforcement implant trial

    Identifiers

    Type ID
    Primary 08806373583285

    Premarket Submissions

    Submission Number Supplement Number
    K162402 000