BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lordotic Cage, 12 x 11mm

    DI: M739FCL12110 · Model: FCL1211 · CAPTIVA SPINE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lordotic Cage, 12 x 11mm
    Primary DI
    M739FCL12110
    Version / Model
    FCL1211
    Company Name
    CAPTIVA SPINE, INC.
    Labeler DUNS
    836975784
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-21
    Public Version
    4
    Public Version Date
    2020-02-24
    Public Version Status
    Update
    Public Device Record Key
    86583eb5-72df-4227-9684-b0fc535325c3

    Device Description

    Lordotic Cage, 12 x 11mm

    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary M739FCL12110

    Premarket Submissions

    Submission Number Supplement Number
    K110585 000
    K142586 000